Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AB801 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Dose Escalation Cohort 1 - AB801 capsule Dose Level 1 | EXPERIMENTAL | Participants will receive AB801 orally daily |
| Dose Escalation Cohort 2 - AB801 capsule Dose Level 2 | EXPERIMENTAL | Participants will receive AB801 orally daily |
| Dose Escalation Cohort 3 - AB801 capsule Dose Level 3 | EXPERIMENTAL | Participants will receive AB801 orally daily |
| Dose Escalation Cohort 4 - AB801 capsule Dose Level 4 | EXPERIMENTAL | Participants will receive AB801 orally daily |
| Dose Escalation Cohort 5 - AB801 tablets Dose Level 5 | EXPERIMENTAL | Participants will receive AB801 orally daily |
| Dose Escalation Cohort 6 - AB801 tablets Dose Level 6 | EXPERIMENTAL | Participants will receive AB801 orally daily |
| Dose Escalation Cohort 7 - AB801 tablets Dose Level 7 | EXPERIMENTAL | Participants will receive AB801 orally daily |
| Dose Expansion Cohort - AB801 + Docetaxel | EXPERIMENTAL | Participants with NSCLC will receive AB801 orally in combination with docetaxel IV infusion |
| Cohort 1 - AB801 Dose A | EXPERIMENTAL | Participants will receive a single dose of AB801 or placebo |
| Cohort 2 - AB801 Dose B | EXPERIMENTAL | Participants will receive a single dose of AB801 or placebo |
| Cohort 3 - AB801 Dose C | EXPERIMENTAL | Participants will receive a single dose of AB801 or placebo |
| Cohort 4 - AB801 Dose D | EXPERIMENTAL | Participants will receive a single dose of AB801 or placebo |
| Name | Type | Description |
|---|---|---|
| AB801 | DRUG | Administered as specified in the treatment arm |
| Docetaxel | DRUG | Administered as specified in the treatment arm |
| Placebo | DRUG | Administered as specified in the treatment arm |
Key Inclusion Criteria: * Monotherapy-specific criteria for dose escalation cohorts: * Participants may have cytologically or pathologically confirmed non-small cell lung carcinoma (NSCLC), colorectal carcinoma (CRC), breast, ovarian, renal cell carcinoma (RCC), head and neck squamous cell carci...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/ GEH200521- Part A |
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
AB801 is an investigational small molecule being studied for the treatment of cancer and advanced cancer. It is currently in Phase 1 clinical development, with trials evaluating its safety, pharmacokinetics, and pharmacodynamics in healthy volunteers and its activity as monotherapy and combination therapy in participants with advanced malignancies.
AB801 targets AXL, a receptor tyrosine kinase protein involved in tumor progression and metastasis. By inhibiting AXL, AB801 may interfere with signaling pathways that promote cancer cell survival and spread. This mechanism is being explored in early-stage clinical trials for oncology indications.
AB801 is being developed by Arcus Biosciences, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker RCUS. The company is conducting Phase 1 clinical trials to assess the drug's safety and efficacy in cancer patients.
AB801 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials are listed: one completed study in healthy volunteers and one active study in patients with advanced malignancies.
AB801 is being evaluated in two Phase 1 clinical trials. NCT06004921 is a completed study assessing safety, pharmacokinetics, and pharmacodynamics in healthy volunteers in the United Kingdom. NCT06120075 is an active, non-recruiting study of AB801 monotherapy and combination therapy in participants with advanced malignancies in the United States.
Yes, AB801 is being studied as both monotherapy and combination therapy. The Phase 1 trial NCT06120075 is designed to evaluate AB801 alone and in combination with other agents in participants with advanced malignancies, with a target enrollment of 91 participants.