Clinical Trials

First-Line-Therapy (Metastatic Disease/Hematology)

BI 1438-0001

Title: A Study to Test Different Doses of BI 764532 in Patients With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for Delta-Like Ligand 3 (DLL3).
Phase: phase I
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587566
Contact E-Mail-Address: ectu@ukdd.de
Examiner: Prof. Dr. med. habil Martin Wermke
Registration: NCT04429087
EudraCT-number: 2019-000729-31
Description: BI 1438-0001 is a multicenter, open-label, Phase I dose-escalation and expansion study investigating the bispecific T-cell engager BI 764532 in DLL3-positive neoplasms. The study enrolls adult patients with small cell lung cancer (SCLC), large cell neuroendocrine lung carcinoma (LCNEC), or extrapulmonary neuroendocrine carcinomas (epNEC) that are locally advanced or metastatic and have progressed after standard therapy. The primary objective is to determine the maximum tolerated dose (MTD) and identify dose-limiting toxicities (DLTs). DLL3 expression is verified via immunohistochemistry during central screening. The investigational product is administered intravenously in escalating doses to evaluate the pharmacokinetic profile and safety. Key secondary endpoints include the objective response rate (ORR) per RECIST 1.1 and duration of response (DOR).

IOV-MEL-301

Title: A Phase 3, Multicenter, Randomized, Open-label, Parallel Group, Treatment Study to Assess the Efficacy and Safety of the Lifileucel (LN-144, Autologous Tumor Infiltrating Lymphocytes [TIL]) Regimen in Combination With Pembrolizumab Compared With Pembrolizumab Monotherapy in Participants With Untreated, Unresectable or Metastatic Melanoma
Phase: phase III
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587566
Contact E-Mail-Address: ectu@ukdd.de
Examiner: Prof. Dr. med. habil Martin Wermke
Registration: NCT05727904
EudraCT-number: 2022-503140-41
Description: This is a Phase 3, multicenter, open-label, randomized, parallel group, treatment studyto assess the efficacy and safety of lifileucel in combination with pembrolizumabcompared with pembrolizumab alone in participants with untreated, unresectable ormetastatic melanoma. Participants randomized to the pembrolizumab monotherapy arm whosubsequently have a blinded independent central review- verified confirmed progressivedisease (PD) will be offered lifileucel monotherapy in an optional crossover period.

Anocca-VIDAR-1

Title: Protocol Title: Phase 1/2 Master Protocol for Open-Label, Multi-Centre, Single-Arm Sub-Studies, First in Human Clinical Studies of TCR-T Therapy (Autologous TCR-Modified T-Cell Therapy) Targeting Mutated Kirsten Rat Sarcoma (mutKRAS) Administered in Metastatic or Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) Adult Patients with Specific mutKRAS and Human Leukocyte Antigen (HLA) Genotypes.
Phase: phase I/II
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587566
Contact E-Mail-Address: ectu@ukdd.de
Examiner: Prof. Dr. med. habil Martin Wermke
Registration: NCT07145450
EudraCT-number: 2024-513900-32
Description: The “Master Protocol of TCR-modified T Cell Therapy Targeting HLA-restricted KRAS Antigen” (NCT07145450) is a multicentre, open-label Phase 1/2 trial of autologous, gene-modified TCR-T cell therapy (ANOC-001 / ANOC-002 targeting KRAS G12V; ANOC-003 targeting KRAS G12D) in adult patients with metastatic or locally advanced pancreatic ductal adenocarcinoma. The primary objective is to assess safety, persistence, expansion, and preliminary antitumor activity of the infused T cells. Eligible participants must have confirmed PDAC with KRAS G12V or G12D mutation and compatible HLA genotype, measurable disease per RECIST 1.1, and prior standard-of-care first-line therapy. After lymphodepletion with cyclophosphamide and fludarabine, patients receive a single IV infusion of TCR-T cells (non-randomized, single-arm design). Secondary endpoints include T cell persistence and expansion, as well as clinical response and disease stabilization.

Avencell AVC-201-01

Title: Multicenter, Open-label, Phase 1 Study of Allo-RevCAR01-T-CD123 Consisting of Genetically Modified T cells Carrying Reverse Chimeric Antigen Receptors (Allo-RevCAR01-T) in Combination With CD123 Target Module (R-TM123) for the Treatment of Patients With Selected Hematologic Malignancies Positive for CD123.
Phase: phase I
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587566
Contact E-Mail-Address: ectu@ukdd.de
Examiner: Prof. Dr. med. habil Martin Wermke
Registration: NCT05949125
EudraCT-number: 2022-501797-19
Description: AVC-201-01 is a multicenter, open-label, Phase I study evaluating Allo-RevCAR01-T cells in combination with the CD123 target module (R-TM123) for CD123-positive hematologic malignancies. The innovative RevCAR system allows for pharmacological control of CAR-T cell activity via the administered target module. The primary objective is to evaluate safety and determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D). Eligible participants include adult patients with recurrent or refractory acute myeloid leukemia (AML), blastic plasmacytoid dendritic cell neoplasm (BPDCN), or myelodysplastic syndromes (MDS). CD123 expression is confirmed during screening. Following lymphodepletion, patients receive allogeneic RevCAR-T cells and sequential infusions of R-TM123. Key secondary endpoints include the pharmacokinetics of the T cells and the target module, as well as preliminary anti-leukemic activity.

Pierre Fabre F60089IV101 VERT-002

Title: A First-In-Human (FIH) Phase I/II Open-label, Multicentre, Dose Escalation and Expansion Trial of VERT-002 in Patients With Locally Advanced or Metastatic Solid Tumors Including Non-small Cell Lung Cancer (NSCLC) Harboring Mesenchymal-Epithelial Transition (MET) Alterations
Phase: phase I/II
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587566
Contact E-Mail-Address: ectu@ukdd.de
Examiner: Prof. Dr. med. habil Martin Wermke
Registration: NCT06669117
Description: The trial NCT06669117 is a first-in-human, open-label Phase I/II study of VERT-002 (PFL-002), an intravenous c-MET degrader, in adults with locally advanced or metastatic solid tumors harboring documented MET gene alterations (e.g., MET ex14 skip, activating MET kinase-domain mutations, or MET amplification). The primary objective is to evaluate safety, tolerability and to determine the maximum tolerated dose (MTD) and/or optimal biologically active dose (OBD). Eligible adults have tumors for which no standard therapy is available, or NSCLC Stage IIIB/C or IV, with measurable disease per RECIST 1.1 and ECOG performance status 0–1. MET alteration status is confirmed at screening via local or central testing. Participants receive VERT-002 in a sequential dose-escalation followed by expansion cohort. Key secondary endpoints include pharmacokinetics, objective response rate and safety profile.

Second line + Treatment (Metastatic Disease)

Amgen 20230153

Title: A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of AMG 193 in Subjects with Methylthioadenosine Phosphorylase (MTAP)-deleted Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC).
Phase: phase II
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587566
Contact E-Mail-Address: ectu@ukdd.de
Examiner: Prof. Dr. med. habil Martin Wermke
Registration: NCT06593522
EudraCT-number: 2024-514459-14
Description: The Phase II MTAPESTRY 201 trial evaluates the investigational agent AMG 193 in adults with histologically or cytologically confirmed, metastatic or unresectable locally advanced non-small cell lung cancer (NSCLC) harboring a homozygous deletion of the MTAP gene. The primary objective is to characterize the safety, tolerability, pharmacokinetics and efficacy of two dose levels of AMG 193 via investigator assessment and a Blinded Independent Central Review (BICR). Key inclusion criteria include prior systemic therapy, availability of archived tumor tissue, life expectancy greater than three months, and treated or stable brain metastases = 2 cm without need for corticosteroids. The molecular status (MTAP homozygous deletion) is confirmed during screening; patients with actionable driver mutations (EGFR, ALK, ROS1, NTRK, MET, BRAF, RET, HER2, KRAS G12C) are excluded. Treatment is administered orally once daily in 28-day cycles in a sequential dose-escalation and expansion design. Important secondary endpoints include safety profiles, PK parameters and preliminary response rates.

CURIS CA-4948-104

Title: A PHASE 1 SINGLE-ARM, OPEN-LABEL STUDY OF CA-4948 IN COMBINATION WITH AZACITIDINE AND VENETOCLAX IN ACUTE MYELOID LEUKEMIA PATIENTS IN COMPLETE RESPONSE WITH MEASURABLE RESIDUAL DISEASE.
Phase: phase I
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587566
Contact E-Mail-Address: ectu@ukdd.de
Examiner: Prof. Dr. med. habil Martin Wermke
EudraCT-number: 2023-505828-58
Description: A Phase 1 Single-Arm, Open-Label Study of CA-4948 in Combination with Azacitidine and Venetoclax in Acute Myeloid Leukemia Patients in Complete Response with Measurable Residual Disease.

BI 1438-0009/ DAREON-9

Title: DAREON-9: A Phase Ib Open-label Dose Escalation and Dose Confirmation Safety Study of Intravenous BI 764532 in Combination With Topotecan for the Treatment of Patients With Small Cell Lung Cancer
Phase: phase I
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587566
Contact E-Mail-Address: ectu@ukdd.de
Examiner: Prof. Dr. med. habil Martin Wermke
Registration: NCT05990738
EudraCT-number: 2023-506007-26
Description: DAREON-9 is an open-label, multicentre, Phase Ib dose escalation and dose confirmation safety study evaluating the bispecific T-cell engager (BiTE) BI 764532 in combination with Topotecan in patients with small cell lung cancer (SCLC). The primary objective is to determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RP2D) of BI 764532 in combination with Topotecan. Eligible participants are adult patients with extensive stage SCLC who have progressed after prior platinum-based chemotherapy and are eligible for Topotecan treatment. BI 764532 is administered intravenously, while Topotecan can be given intravenously or orally. Key secondary endpoints include assessing the safety and tolerability of the combination and evaluating the objective response rate (ORR) and duration of response (DoR) according to RECIST v1.1.

IOV-LUN-202

Title: A Phase 2 Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients With Metastatic Non-Small-Cell Lung Cancer
Phase: phase II
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587566
Contact E-Mail-Address: ectu@ukdd.de
Examiner: Prof. Dr. med. habil Martin Wermke
Registration: NCT04614103
EudraCT-number: 2020-003629-45
Description: The Phase II IOV-LUN-202 trial is an open-label, multicenter, non-randomised cohort study evaluating the autologous tumor-infiltrating lymphocyte therapy LN-145 in adults with metastatic non-small-cell lung cancer (NSCLC) lacking EGFR, ALK or ROS1 driver mutations. The primary objective is to assess the objective response rate (ORR) per RECIST 1.1. Eligible patients are adults with documented radiographic progression following at least one line of systemic therapy including an immune checkpoint inhibitor plus platinum-based chemotherapy. Screening excludes the presence of EGFR, ALK and ROS1 driver mutations. Treatment is delivered in sequence: a non-myeloablative lymphodepleting preparative regimen followed by LN-145 infusion and IL-2 administration in non-randomised cohorts. Key secondary endpoints include duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and the safety profile.

RMC-Lung-101:

Title: A Platform Study of RAS(ON) Inhibitor Combinations in Patients with RAS-Mutated Non-Small Cell Lung Cancer (NSCLC)
Phase: phase I/II
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587566
Contact E-Mail-Address: ectu@ukdd.de
Examiner: Prof. Dr. med. habil Martin Wermke
Registration: NCT06162221
Description: The trial NCT06162221 is an open-label, multicenter Phase?1/2 platform interventional study evaluating novel RAS(ON) inhibitors in adults with advanced or metastatic non-small cell lung cancer (NSCLC) harbouring documented RAS gene mutations (e.g., KRAS, NRAS, HRAS). The primary objective is to establish recommended Phase?2 dose (RP2D) and assess objective response rate (ORR) across multiple sub-protocols. Eligible participants have ECOG performance status 0–1, adequate organ function, confirmed RAS-mutation and non-curatively treatable advanced or metastatic disease. Molecular RAS-mutation status is confirmed at screening. Patients are enrolled non-randomised in parallel cohorts (e.g., RMC-6291 ± RMC-6236 + pembrolizumab ± chemotherapy; RMC-6236 + pembrolizumab ± chemotherapy; RMC-9805 ± RMC-6236 + pembrolizumab ± chemotherapy; RMC-9805 monotherapy). Key secondary endpoints include duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety/tolerability profiles.

Lilly J5J-OX-JZZA

Title: A Phase 1a/1b Trial of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors
Phase: phase I
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587566
Contact E-Mail-Address: ectu@ukdd.de
Examiner: Prof. Dr. med. habil Martin Wermke
Registration: NCT06586515
EudraCT-number: 2024-516440-25
Description: The main purpose of this study is to assess safety & tolerability and antitumor activityof LY3962673 as monotherapy and in combination with other chemotherapy agents inparticipants with KRAS G12D-mutant advanced solid tumor types. The study is expected tolast approximately 5 years.

Second line + Treatment

T-CURX SIGBLAST1

Title: A phase l, first-in-human study evaluating the safety, tolerability, and efficacy of autologous T-cells carrying a Siglec-6-specific chimeric antigen receptor (CAR) in adult patients with Refractory or Relapsed (RR) Acute Myeloid Leukemia (AML) or Chronic Lymphocytic Leukemia (CLL)
Phase: phase I
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587566
Contact E-Mail-Address: ectu@ukdd.de
Examiner: Dr. med. Martin Wermke
EudraCT-number: 2023-508796-37
Description: A phase l, first-in-human study evaluating the safety, tolerability, and efficacy of autologous T-cells carrying a Siglec-6-specific chimeric antigen receptor (CAR) in adult patients with Refractory or Relapsed (RR) Acute Myeloid Leukemia (AML) or Chronic Lymphocytic Leukemia (CLL)

other systemic therapies

Pierre Fabre STX-241 (SILVER)

Title: Phase I/II First-In-Human Open-label Trial to Assess Safety and Efficacy of STX-241 in Participants with Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Resistant to EGFR Tyrosine Kinase Inhibitors (TKIs).
Phase: phase I/II
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587566
Contact E-Mail-Address: ectu@ukdd.de
Examiner: Prof. Dr. med. habil Martin Wermke
Registration: NCT06567015
EudraCT-number: 2023-510203-21
Description: The goal of this First-In-Human (FIH) Phase I/II trial is to establish the safetyprofile, determine the Recommended Phase II Dose (RP2D), explore the pharmacokinetic (PK)exposure and pharmacodynamic (PD) properties as well as assess the efficacy of STX-241, amutant selective Central Nervous System (CNS)-penetrant fourth generation EGFR TKI, inparticipants with locally advanced or metastatic NSCLC that progressed during orfollowing third generation EGFR TKI such as osimertinib due to C797X double acquired(secondary) mutations.

Immatics IMA 203-101

Title: Phase 1 Study Evaluating Genetically Modified Autologous T Cells Expressing a T-cell Receptor Recognizing a Cancer/Germline Antigen in Patients With Relapsed and/or Refractory Solid Tumors (ACTengine IMA203-101)
Phase: phase I
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587566
Contact E-Mail-Address: ectu@ukdd.de
Examiner: Prof. Dr. med. habil Martin Wermke
Registration: NCT03686124
EudraCT-number: 2019-002370-31
Description: SCREENING: Patient eligibility will be determined by HLA (human leukocyte antigen) screening and a biopsy for biomarker screening. If the patient is eligible, white blood cells will be taken during leukapheresis for the manufacture of the IMA203 product. MANUFACTURING: IMA203 product will be made from the patient's white blood cells. TREATMENT: Lymphodepletion with cyclophosphamide and fludarabine will occur in the days before the IMA203 product infusion to improve the duration of time that IMA203 product stays in the body. The patient will be admitted to the hospital during the treatment. After the IMA203 product infusion, a low dose of IL-2 will be given subcutaneously twice daily for 14 days. Since this study involves gene therapy, patients will be monitored throughout the study and for up to a total of 15 years.

Prelude PRT2527

Title: A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT2527 as Monotherapy and in Combination with Zanubrutinib or Venetoclax in Participants with Relapsed/Refractory Hematologic Malignancies.
Phase: phase I
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587566
Contact E-Mail-Address: ectu@ukdd.de
Examiner: Prof. Dr. med. habil Martin Wermke
Registration: NCT05665530
EudraCT-number: 2022-502672-23
Description: A Phase 1 Study of PRT2527 as Monotherapy and in Combination with Zanubrutinib or Venetoclax in Participants with Relapsed/Refractory Hematologic Malignancies.

PXS5505-MDS-101

Title: A phase Ib/II multicenter open-label study evaluating the safety and efficacy of escalating doses of PXS-5505 for pan-LOX/LOXL inhibition in combination with 5-Azacitidine in patients diagnosed with Myelodysplastic Neoplasms (MDS) or Chronic Myelomonocytic Leukemia (CMML).
Phase: phase I/II
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587566
Contact E-Mail-Address: ectu@ukdd.de
Examiner: Dr. Katja Sockel
EudraCT-number: 2024-517237-40
Description: The AZALOX Study (PXS5505-MDS-101) is a multicenter, open-label Phase Ib/II study evaluating the safety and pharmacokinetics of escalating doses of the pan-LOX/LOXL inhibitor PXS-5505 in combination with 5-azacitidine. The study targets patients diagnosed with Myelodysplastic Neoplasms (MDS) or Chronic Myelomonocytic Leukemia (CMML). Primary endpoints for Phase Ib include dose-limiting toxicity (DLT), determination of the recommended Phase II dose (RP2D), and the overall safety profile. The trial enrolls adult patients with MDS or CMML in the first-line setting or following prior therapy, who are eligible for azacitidine treatment. Participants receive oral PXS-5505 in combination with 5-azacitidine. Key secondary endpoints include the assessment of overall response rate (ORR), duration of response (DOR), and hematological improvement (HI).

Scorpion STX-721-101

Title: First-In-Human Study of STX-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations
Phase: phase I
Legal foundation: Arzneimittelgesetz
Examiner: Prof. Dr. med. habil Martin Wermke
Registration: NCT06043817
EudraCT-number: 2023-506759-51
Description: Study STX-721-101 is an open label, Phase 1/2 study evaluating the safety, tolerability,pharmacokinetic (PK) exposure, and preliminary antitumor activity of STX-721 inparticipants with non-small cell lung cancer (NSCLC) carrying EGFR/HER2 exon 20 insertion(ex20ins) mutations.

Beigene BGB-16673

Title: A Phase 1/2, Open-Label, Dose-Escalation and -Expansion Study of the Bruton Tyrosine Kinase Targeted Protein Degrader BGB-16673 in Patients With B-Cell Malignancies
Phase: phase I/II
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587566
Contact E-Mail-Address: ectu@ukdd.de
Examiner: Prof. Dr. med. Johannes Schetelig
Registration: NCT05006716
EudraCT-number: 2022-502157-33
Description: Study consists of two main parts to explore BGB-16673 recommended dosing, a Phase 1monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safetyexpansion of selected doses, and a Phase 2 (expansion cohorts)

IMA203-301

Title: This clinical trial is a prospective, multicenter, open-label, randomized, actively controlled, parallel-group Phase 3 clinical trial to evaluate the efficacy, safety and tolerability of treatment with IMA203 administered at the recommended phase 2 dose versus investigator's choice of treatment in patients with previously treated, unresectable or metastatic cutaneous melanoma
Phase: phase III
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587566
Contact E-Mail-Address: ectu@ukdd.de
Examiner: Prof. Dr. med. habil Martin Wermke
Registration: NCT06743126
EudraCT-number: 2024-517062-42
Description: The trial NCT036861243 is an open-label Phase?1 study evaluating the safety, tolerability, and pharmacokinetics of IMA203, an autologous T-cell therapy, in adults with advanced solid tumors. The primary objective is to assess safety and identify dose-limiting toxicities. Eligible patients have histologically or cytologically confirmed solid tumors for which no standard therapy is available. Eligibility is confirmed via HLA typing and biomarker analysis of tumor biopsies. The intervention includes leukapheresis, manufacturing of IMA203 from autologous T cells, lymphodepletion with cyclophosphamide and fludarabine, followed by IMA203 infusion and 14-day subcutaneous IL-2 administration. Key secondary endpoints include pharmacokinetics, immunologic responses, objective tumor responses, and long-term safety monitoring for up to 15 years.

Prelude PRT3789-01

Title: A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT3789 as Monotherapy and in Combination With Docetaxel in Participants With Advanced or Metastatic Solid Tumors With a SMARCA4 Mutation
Phase: phase I
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587566
Contact E-Mail-Address: ectu@ukdd.de
Examiner: Prof. Dr. med. habil Martin Wermke
Registration: NCT05639751
EudraCT-number: 2022-502850-14
Description: This is a Phase 1 dose-escalation study of PRT3789, a SMARCA2 degrader, in participantswith advanced or metastatic solid tumors with loss of SMARCA4 due to truncating mutationand/or deletion. The purpose of this study is to evaluate the safety, tolerability,pharmacokinetic (PK), and pharmacodynamic (PD) of PRT3789 monotherapy and in combinationwith docetaxel, describe any dose limiting toxicities (DLTs), define the dosing schedule,and to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) tobe used in subsequent development of PRT3789.

IMA402 (bispecific T cell engaging receptor molecule)

Title: A Phase I/II First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Anti-Tumor Activity of IMA402, a Bispecific T Cell-Engaging Receptor Molecule (TCER®) targeting PRAME, in Patients with Recurrent and/or Refractory Solid Tumors.
Phase: phase I/II
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587566
Contact E-Mail-Address: ectu@ukdd.de
Examiner: Prof. Dr. med. habil Martin Wermke
Registration: NCT05958121
EudraCT-number: 2022-503133-54
Description: IMA402-101 is a multicenter, open-label, Phase I dose-escalation study evaluating the bispecific T-cell receptor (TCER®) molecule IMA402 in patients with PRAME-positive solid tumors. The primary objective is to evaluate safety, tolerability, and to determine the recommended Phase II dose (RP2D) based on dose-limiting toxicities (DLTs). Eligible participants include adult patients with recurrent or refractory malignancies, including cutaneous and uveal melanoma as well as non-small cell lung cancer. Enrollment requires confirmation of the HLA-A*02:01 haplotype and documented PRAME expression within the tumor tissue. The investigational product is administered intravenously in ascending dose cohorts. Key secondary endpoints include pharmacokinetics and preliminary anti-tumor activity assessed by RECIST v1.1 criteria.