NCT05721222

Trial of PRO1160 (GEN1160) in Relapsed or Refractory Non-Hodgkin Lymphoma (NHL) (PRO1160-001)

Terminated Phase 1, PHASE2 Last updated 4 March 2026

What this trial tests

Phase 1, PHASE2 trial testing GEN1160 in Renal Cell Carcinoma in 42 participants. Terminated before completion.

Timeline

15 March 2023

Primary endpoint
5 November 2025

5 November 2025

Quick facts

Lead sponsor	Genmab
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	42
Start date	15 March 2023
Primary completion	5 November 2025
Estimated completion	5 November 2025
Sites	17 locations across China, United States

Drugs / interventions tested

• GEN1160 — full drug profile →

Conditions studied

• Renal Cell Carcinoma — all drugs for Renal Cell Carcinoma →
• Nasopharyngeal Carcinoma — all drugs for Nasopharyngeal Carcinoma →
• Non Hodgkin Lymphoma — all drugs for Non Hodgkin Lymphoma →

Sponsor

Genmab — full company profile →

Who can join

18 and older, any sex, with Renal Cell Carcinoma or Nasopharyngeal Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Brief Summary:

This study will test the safety, including side effects, and determine the characteristics of a drug called GEN1160 (PRO1160) in participants with solid tumors and blood cancers.

Participants will have cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable) or relapsed or refractory to prior treatments.

This Phase 1/2 study will have three parts. The dose escalation part of the study will find out how much and how frequently GEN1160 should be given to participants. The expansion Part A and expansion Part B will use the dose and schedule found in the dose escalation part to find out how safe GEN1160 is and if it works to treat the diseases under study. The diseases under study will be Renal Cell Carcinoma (RCC), Nasopharyngeal Carcinoma (NPC) and Non-Hodgkin Lymphoma (NHL) in Escalation and diffuse large B-cell lymphoma (DLBCL) in expansion Part A and Part B.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Evolving Landscape of Antibody-Drug Conjugates: In Depth Analysis of Recent Research Progress.
   Sasso JM, Tenchov R, Bird R, Iyer KA, et al · · 2023 · cited 89× · PMID 37821099 · DOI 10.1021/acs.bioconjchem.3c00374
2. CD70: An emerging target for integrated cancer diagnosis and therapy.
   Hu J, Li J, Yang B, Wang S, et al · · 2025 · cited 4× · PMID 40629902 · DOI 10.1002/ctm2.70400
3. Novel Therapeutic Development for Nasopharyngeal Carcinoma.
   Kim J, Lee Y, Kim S, Park JC. · · 2025 · PMID 41002550 · DOI 10.3390/curroncol32090479
4. Immune-checkpoint targeting drug conjugates: a novel class of promising therapeutic agents for cancer treatment.
   Marchesi S, Marinello A, Ambrosini P, Cavalli C, et al · · 2025 · PMID 40603576 · DOI 10.1038/s41698-025-01011-7
5. CT-based radiomics model for the prediction of genomic alterations in renal cell carcinoma (RCC)
   · 2023
6. Phase 1/2 study of PRO1160, a CD70-directed antibody-drug conjugate, in patients with advanced solid tumors and hematologic malignancies
   · 2023
7. Circulating and intratumoral immune determinants of response to atezolizumab plus bevacizumab in patients with variant histology or sarcomatoid renal cell carcinoma
   · 2023