A Study of TAK-981 in Participants With Relapsed/Refractory Solid Tumors or Non-Hodgkin Lymphoma (NHL)

Summary

Participation Requirements

Description

The drug being tested in this study is called TAK-981. TAK-981 is being tested to evaluate safety, tolerability, preliminary efficacy and PK in participants with advanced or metastatic solid tumors or relapsed/refractory hematologic malignancies. The study will include 2 phases: Phase 1 dose escalat...

The drug being tested in this study is called TAK-981. TAK-981 is being tested to evaluate safety, tolerability, preliminary efficacy and PK in participants with advanced or metastatic solid tumors or relapsed/refractory hematologic malignancies. The study will include 2 phases: Phase 1 dose escalation and Phase 2 dose expansion cohorts (cancer treatment expansions). The study will enroll approximately 202 participants, approximately 70 participants in the dose escalation phase, approximately 132 participants in cancer treatment expansion phase. In the dose escalation, dose levels will be escalated based on safety, and available PK and pharmacodynamic data and will also determine the single agent RP2D. Participants in dose expansion phase will be enrolled, once RP2D is determined. There will be 6 cohorts in cancer treatment expansions as following: Cohort A: Nonsquamous NSCLC Cohort B: Cervical cancer Cohort C: MSS-CRC Cohort D: Relapsed/refractory DLBCL progressed or relapsed after CAR T-cells therapy Cohort E: Relapsed/refractory DLBCL that have not received prior cellular therapy Cohort F: Relapsed/refractory FL This multi-center trial will be conducted in the United States and Canada. The overall time to participate in this study is approximately 4 years. The overall time to receive treatment in the dose escalation and cancer treatment is approximately 1 year. Based on decision of sponsor, participants with demonstrated clinical benefit can continue treatment beyond 1 year. Participants will make multiple visits to the clinic, and will make a final visit 30 days after receiving their last dose of drug or before the start of subsequent anticancer therapy, whichever occurs first for a follow-up assessment.

Tracking Information