Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EVOLVE104 · 1 trial · 11 indications
TEAEs will be assessed during routine study visits and compared to Baseline to continuously evaluate safety and tolerability
Protocol-defined potential DLTs will be assessed by the Safety Review Committee at routine intervals.
Safety evaluations will occur consistently for each subject and across patients to assess MTD or RDE. Evaluations include analysis of TEAEs as well as ongoing assessments of laboratories, ECGs and physical examinations.
Selection of the RP2D will be based on the aggregate safety, efficacy, PK, and PD observations for the entire study
| Arm | Type | Description |
|---|---|---|
| Phase 1a Cohort 1; dose level 1 | EXPERIMENTAL | Active Study Drug |
| Phase 1a Cohort 2; dose level 2 | EXPERIMENTAL | Active Study Drug |
| Phase 1a Cohort 3; dose level 3 | EXPERIMENTAL | Active Study Drug |
| Phase 1a Cohort 4; dose level 4 | EXPERIMENTAL | Active Study Drug |
| Phase 1a Cohort 5; dose level 5 | EXPERIMENTAL | Active Study Drug |
| Phase 1a Cohort 6; dose level 6 | EXPERIMENTAL | Active Study Drug |
| Phase 1a Cohort 7; dose level 7 | EXPERIMENTAL | Active Study Drug |
| Phase 1a Cohort 8; dose level 8 | EXPERIMENTAL | Active Study Drug |
| Phase 1a Cohort 9; dose level 9 | EXPERIMENTAL | Active Study Drug |
| Phase 1a Cohort 10; dose level 10 | EXPERIMENTAL | Active Study Drug |
| Phase 1b Cohort 1; dose level TBD | EXPERIMENTAL | Active study drug |
| Phase 1b Cohort 2; dose level TBD | EXPERIMENTAL | Active study drug |
| Name | Type | Description |
|---|---|---|
| EVOLVE104 | DRUG | EVOLVE104 is provided as a solution for injection via IV infusion |
Key Inclusion Criteria: Participants must have locally advanced or metastatic cancer with one of the following tumor types: bladder cancer, squamous cell carcinoma of the lung, esophagus, skin, or an anogenital squamous cell carcinoma. 1. Participant must have documented disease progression during...
Top 20 of 51 competitors
EVOLVE104 is an investigational small molecule being studied for the treatment of bladder cancer, including advanced urothelial carcinoma, and for squamous cell carcinomas arising in multiple sites such as the lung, esophagus, tongue, skin, penis, anus, vulva, cervix, vagina, and urethra. It is not yet approved for any indication.
EVOLVE104 is being developed by United Therapeutics Corporation, which trades on the Nasdaq under the ticker UTHR. The company is the sponsor of the clinical program evaluating the agent in advanced urothelial and squamous cell carcinomas.
EVOLVE104 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA or any other regulatory authority. The Phase 1 program is designed to evaluate safety, efficacy, and pharmacokinetics in participants with advanced solid tumors.
EVOLVE104 is being evaluated in one active clinical trial, NCT07217171, titled A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial and Squamous Cell Carcinomas. The trial is currently recruiting, is controlled, and plans to enroll 160 participants aged 18 years and older in the United States.
The NCT07217171 trial enrolls participants with bladder cancer and a range of squamous cell carcinomas, including squamous cell carcinoma of the lung, esophagus, tongue, skin, penis, anus, vulva, cervix, vagina, and urethra. Enrollment is open to adults 18 years and older of any sex, and the study is recruiting in the United States.