Clinical trial · Interventional
CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
A Phase 1/2, Multicenter, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
NCT07335497CI-TRIAL-00124928ASCENDrecruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260911-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the safety and tolerability of monotherapy CR-001 and identify the maximum tolerated dose (MTD), and/or optimal biologic dose and Recommended Phase 2 Dose(s) (RP2D) in participants with locally advanced or metastatic solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced / Metastatic Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CR-001 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- CR-001 Dose escalation
- description
- 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
- interventionNames
- Drug: CR-001
- type
- EXPERIMENTAL
- label
- CR-001 Backfill
- description
- Escalating dose levels of CR-001 Indication-specific cohort populations will be tested
- interventionNames
- Drug: CR-001
- type
- EXPERIMENTAL
- label
- CR-001 Dose Optimization Cohort X
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 and Dose Optimization: Willingness to provide recent archival tumor tissue sample or willingness to undergo biopsy * Tumor Indication specific inclusion criteria: * For dose escalation or backfill: progressing from, intolerant to, or ineligible for (due to unavailability or contraindication) local standard of care therapies and have one of the following locally advanced or metastatic tumor types: * Hepatocellular carcinoma * Biliary tract cancer * Endometrial carcinoma * Cervical cancer * Ovarian cancer * Gastric or gastroesophageal cancer * Colorectal cancer * Non-small cell lung cancer Key Exclusion Criteria * Has malignancies other than disease under study within the past 3 years * Has conditions requiring treatment with clinically significant or increasing doses of systemic steroid therapy * Has not adequately recovered from recent major surgery * Has ongoing clinically significant toxicity related to prior therapy * Has active central nervous system (CNS) metastases * Has active autoimmune disease requiring systemic therapy in the past 2 years (replacement therapy is permitted) * Has a history of serious Grade ≥ 3 immune-related adverse event (irAE) * Has a history of noninfectious pneumonitis/interstitial lung disease * Has an active severe infection * Has received a live or attenuated vaccine within 30 days of the first dose * Has undergone prior allogeneic stem cell or solid organ transplantation * Has protocol-specified events related to gastrointestinal perforation, surgery, wound healing complications, and bleeding * Has clinically significant cardiovascular disease NOTE: Other protocol defined Inclusion and Exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.