NCT04381650

A Study of TAK-981 Given With Pembrolizumab in Participants With Select Advanced or Metastatic Solid Tumors

A Phase 1b/2 Study of TAK-981 Plus Pembrolizumab to Evaluate the Safety, Tolerability, and Antitumor Activity of the Combination in Patients With Select Advanced or Metastatic Solid Tumors

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

TAK-981 is being tested in combination with pembrolizumab to treat participants who have select advanced or metastatic solid tumors. The study aims are to evaluate the safety, tolerability, and preliminary efficacy of TAK-981 in combination with pembrolizumab. Participants will be on this combination treatment for 21-day cycles. They will continue with this treatment for up to 24 months or until participants meet any discontinuation criteria.

Detailed description

The drug being tested in this study is called TAK-981. TAK-981 is being tested to treat people who have select advanced or metastatic solid tumors. The study will include a dose escalation phase and a dose expansion phase. The study will enroll approximately 231 participants, approximately 32 participants in the dose escalation phase 1 and approximately 76 to 199 participants in the 8 cohorts of dose expansion phase 2. Participants will receive escalating doses of TAK-981 and fixed dose of pembrolizumab until recommended phase 2 dose (RP2D) is determined: • Dose Escalation: TAK-981 + Pembrolizumab (Fixed Dose) Once Phase 2 doses are identified, participants of select advanced or metastatic solid tumors will receive TAK-981 in below defined cohorts in the expansion phase 2: * Dose Expansion Phase: Cohort A: Non-squamous Non-small Cell Lung Cancer (NSCLC) * Dose Expansion Phase: Cohort B: Cervical Cancer * Dose Expansion Phase: Cohort C: Microsatellite Stable Colorectal Cancer (MSS-CRC) * Dose Expansion Phase: Cohort D: Cutaneous Melanoma * Dose Expansion Phase: Cohort E: Squamous NSCLC * Dose Expansion Phase: Cohort F: Checkpoint Inhibitors (CPI) Refractory Squamous or Nonsquamous NSCLC This multi-center trial will be conducted worldwide. The overall time to participate in this study is 60 months. Participants will make multiple visits to the clinic, and progression-free survival follow-up for maximum up to 12 months after last dose of study drug.

Conditions

• Advanced or Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	TAK-981	TAK-981 IV infusion.
DRUG	Pembrolizumab	Pembrolizumab IV infusion.

Timeline

• Start date: 2020-08-17
• Primary completion: 2024-10-29
• Completion: 2024-10-29
• First posted: 2020-05-11
• Last updated: 2025-12-10
• Results posted: 2025-12-10

Locations

52 sites across 9 countries: United States, Brazil, China, Croatia, Japan, Latvia, Lithuania, Poland, Switzerland

Regulatory

• FDA-regulated drug study