Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CR-001 · 1 trial · 1 indication
Per cohort
Per Cohort
Events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
| Arm | Type | Description |
|---|---|---|
| CR-001 Dose escalation | EXPERIMENTAL | Escalating dose levels of CR-001 to define the maximum tolerated dose of CR-001 in participants with locally advanced or metastatic solid tumors who are refractory to or unable to tolerate standard of care treatment, or for whom standard of care treatment is unavailable |
| CR-001 Backfill | EXPERIMENTAL | Escalating dose levels of CR-001 Indication-specific cohort populations will be tested |
| CR-001 Dose Expansion 3A: First-line (1L) Non-small cell lung cancer | EXPERIMENTAL | CR-001 in combination with paclitaxel or pemetrexed + carboplatin |
| CR-001 Dose Expansion 3B: First-line (1L) colorectal cancer | EXPERIMENTAL | CR-001 in combination with FOLFOX |
| CR-001 Dose Expansion 3C: Third-line (3L) colorectal cancer | EXPERIMENTAL | CR-001 in combination with trifluridine + tipiracil |
| CR-001 Dose Expansion 3D: First-line (1L) endometrial carcinoma | EXPERIMENTAL | CR-001 in combination with paclitaxel + carboplatin |
| CR-001 Dose Expansion 3E: First-line (1L) gastric/gastroesophageal cancer | EXPERIMENTAL | CR-001 in combination capecitabine + oxaliplatin |
| CR-001 Dose Expansion 3F: Second-line (2L) gastric/gastroesophageal cancer | EXPERIMENTAL | CR-001 in combination with paclitaxel |
| CR-001 Dose Expansion 3G: First-line (1L) Biliary tract cancer | EXPERIMENTAL | CR-001 in combination with gemcitabine + cisplatin |
| CR-001 Dose Optimization Cohort X | EXPERIMENTAL | monotherapy dose level (DL)-X Indication-specific cohort populations will be tested |
| CR-001 Dose Optimization Cohort Y | EXPERIMENTAL | monotherapy dose level (DL)-Y Indication-specific cohort populations will be tested |
| Name | Type | Description |
|---|---|---|
| CR-001 | DRUG | Intravenous Infusion |
| Paclitaxel | DRUG | Intravenous Infusion |
| trifluridine and tipiracil | DRUG | Oral |
| Pemetrexed | DRUG | Intravenous Infusion |
| Carboplatin | DRUG | Intravenous Infusion |
| Oxaliplatin | DRUG | Intravenous Infusion |
| Gemcitabin | DRUG | Intravenous Infusion |
| Cisplatin | DRUG | Intravenous Infusion |
| Capecitabine | DRUG | Oral |
| FOLFOX | DRUG | Intravenous Infusion + Oral |
Key Inclusion Criteria * Life expectancy ≥ 3 months * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1 * Adequate organ function and hematologic reserve based on laboratory parameters * Have measurable disease defined by RECIST v1.1 * For Backfill, Dose Expansion and Dose...
CR-001 is an investigational small molecule in Phase 1 development by Crescent Biopharma, Inc. It is being studied in adults with locally advanced or metastatic solid tumors. CR-001 is designed to act on PD-1, a protein target, and is not yet approved for any use.
CR-001 is being evaluated as a treatment for adults with locally advanced or metastatic solid tumors. The Phase 1 study enrolls participants 18 years and older with these advanced cancers. Because CR-001 remains investigational, it is available only through clinical research, not routine clinical practice.
CR-001 targets PD-1, a protein. PD-1 is a checkpoint receptor on immune cells, and CR-001 is a small molecule designed to bind this protein target. This mechanism is being explored in a Phase 1 oncology study in adults with locally advanced or metastatic solid tumors.
CR-001 is being developed by Crescent Biopharma, Inc., which trades under the ticker CBIO. The company is running the Phase 1 program for CR-001 in locally advanced or metastatic solid tumors across sites in the United States, Australia, France, Ireland, Italy, Romania, South Korea, Spain, and the United Kingdom.
CR-001 is in Phase 1 clinical development. It is investigational and has not completed a pivotal program. The single active trial is a recruiting Phase 1 study in adults with locally advanced or metastatic solid tumors, with planned enrollment of 540 participants.
CR-001 is being studied in trial NCT07335497, titled CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors. This recruiting Phase 1 study plans to enroll 540 participants aged 18 and older, includes a controlled design, and is not randomized or double blinded.
Yes, CR-001 is also known as 001. Both names refer to the same investigational small molecule from Crescent Biopharma, Inc. that targets PD-1 and is in Phase 1 testing for locally advanced or metastatic solid tumors.