Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CTX-471 · 2 trials · 10 indications
Objective Response Rate (ORR) (Percentage of Participants With Objective Response) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Incidence of treatment emergent adverse events (TEAEs), treatment-related AEs (TREAEs), and serious adverse events (SAEs)
Efficacy, exposure, safety events, and markers of response will be aggregated to select a Phase 2 dose
| Arm | Type | Description |
|---|---|---|
| Dose Level 0.3 mg/kg | EXPERIMENTAL | - |
| Dose Level 0.6 mg/kg | EXPERIMENTAL | - |
| Arm 1 Part 1 Dose Escalation | EXPERIMENTAL | Escalating doses of CTX-471 depending on cohort at enrollment |
| Arm 1 Part 2 Dose Expansion | EXPERIMENTAL | Two dose groups of CTX-471 (0.3 mg/kg and 0.6 mg/kg) |
| Arm 2 Part 1 Dose Escalation | EXPERIMENTAL | Escalating doses of CTX-471 in combination with pembrolizumab (KEYTRUDA® ) depending on cohort at enrollment |
| Arm 2 Part 2 Dose Expansion | EXPERIMENTAL | Two cohorts of CTX-471 (0.3 mg/kg and 0.6 mg/kg) in combination with pembrolizumab (KEYTRUDA® ) (400 mg) in three tumor type subgroups. Cohort 1 - Group 1A - NSCLC , Group 1B -SCLC and Group 1C - Melanoma. Cohort 2 Group 2A - NSCLC, Group 2B - SCLC and Group 2C -Melanoma. |
| Name | Type | Description |
|---|---|---|
| CTX-471 | DRUG | Patients will receive CTX-471 as an intravenous (IV) infusion every 2 weeks until disease progression or unacceptable toxicity. |
| Pembrolizumab (KEYTRUDA®) | DRUG | IV infusion every 6 weeks |
Inclusion Criteria: 1. Age 18 years or older. 2. Positive immunohistochemical staining for NCAM (defined as ≥ 1% of malignant cells with membranous/cytoplasmic staining of any intensity) on an archived (≤ 3 months) or freshly taken biopsy specimen (centrally tested) with histologically confirmed di...
CTX-471 is an investigational small molecule being developed for oncology indications, including locally advanced solid tumors and neuroendocrine neoplasms. It is being studied in patients with metastatic or locally advanced malignancies, including non-small cell lung cancer, small cell lung cancer, mesothelioma, melanoma, and head and neck cancer, as well as in NCAM-positive neuroendocrine neoplasms.
CTX-471 targets CD137, a protein involved in immune cell activation. By targeting CD137, CTX-471 is designed to modulate the immune response against tumors. It is being evaluated as a monotherapy and in combination with pembrolizumab in patients who have previously received PD-1/PD-L1 inhibitors.
CTX-471 is being developed by Compass Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol CMPX. The company is conducting clinical trials to evaluate the safety and efficacy of CTX-471 in various oncology indications.
CTX-471 is in Phase 1 and Phase 2 clinical development. A Phase 1 study has been completed, and a Phase 2 study is planned but has not yet started recruiting. The drug is investigational and has not been approved by regulatory authorities.
CTX-471 has been studied in clinical trial NCT03881488, a Phase 1 trial evaluating it as a monotherapy or in combination with pembrolizumab in patients with metastatic or locally advanced malignancies. A Phase 2 trial, NCT07684170, is planned to study CTX-471 in patients with NCAM-positive neuroendocrine neoplasms.
CTX-471 is the sole name provided for this investigational drug. It is being studied under this name in clinical trials, and no alternative names have been reported. The drug is a small molecule targeting CD137 and is being developed by Compass Therapeutics.