Finding studies
Finding studies
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Lead
Takeda
With
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
