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ASCENDNCT07335497

CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors

StatusRecruiting
PhasePhase 1/2
Primary completion (estimated)

At risk: Primary endpoint(s) modified.

See at-risk trials from Crescent Biopharma, Inc.

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Record History

All 18 versions: 18 with changes below. See every version on ClinicalTrials.gov ↗

  1. Enrollment increased: 290 → 540 participants Show 7 more changesShow less
    • Primary endpoint(s) modified
    • Trial sites expanded: 31 → 34 locations
    • Interventions modified
    • Trial arms changed: 4 → 11
    • Eligibility criteria expanded, about 137 words
    • Secondary endpoints: 15 to 16
    • Study description expanded, about 17 words
  2. Study sites: 30 to 31v17
  3. Study sites: 28 to 30v16
  4. Study sites: 26 to 28v15
  5. Study sites: 25 to 26v14
  6. Trial sites expanded: 22 → 25 locationsv13
  7. Study sites: 20 to 22v12
  8. Study sites: 19 to 20v11
  9. Study sites: 17 to 19v10
  10. Trial sites expanded: 12 → 17 locationsv9
  11. Study sites: 10 to 12v8
  12. Study sites: 9 to 10v7
  13. Study sites: 8 to 9v6
  14. Trial sites expanded: 5 → 8 locationsv5
  15. Start date changed from estimate of Feb 2026 to Feb 17, 2026v4
  16. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 5 of 5 sites
    v3
  17. Eligibility criteria shortened, about 19 wordsv2
  18. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Part 1 (Dose Escalation) - Incidence and nature of dose-limiting toxicities
Timeframe: From the first dose of study drug up until approximately 1 month
Part 1 (Dose Escalation) - Characterization of the maximum tolerated dose, if applicable
Timeframe: From the first dose of study drug up until approximately 1 month
All parts - Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and treatment - emergent serious adverse events
Timeframe: From the first dose of study drug until 90 days after the last dose of study drug
All parts - Incidence and severity of TEAEs leading to dose modifications
Timeframe: From the first dose of study drug until 90 days after the last dose of study drug
All parts - Incidence and severity of TEAEs leading to treatment discontinuation
Timeframe: From the first dose of study drug until 90 days after the last dose of study drug
Part 3 (Dose Expansion) - Overall response rate (ORR) by Investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Timeframe: From the first dose of study drug until 90 days after the last dose of study drug

Secondary (10)

All parts - Determination of recommended Phase 2 dose(s)
All parts - Serum CR-001 pharmacokinetic parameters
All parts - Incidence of participants with detectable antidrug antibodies
Parts 1, 2 and 4 - Overall response rate
Parts 1, 2 and 4 - Duration of response
Show 5 moreShow less
Parts 1, 2 and 4 - Time to response
Parts 1, 2 and 4 - Progression free survival
Parts 1, 2 and 4 - Overall survival
Parts 1, 2 and 4 - Best percent change in target lesions
Part 3 (Dose Expansion) - DOR, DCR, TTR, PFS, OS, and best percentage change in target lesions

Arms and interventions

CR-001 Dose escalationExperimental

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 BackfillExperimental

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 cancerExperimental

CR-001 in combination with paclitaxel or pemetrexed + carboplatin

CR-001 Dose Expansion 3B: First-line (1L) colorectal cancerExperimental

CR-001 in combination with FOLFOX

CR-001 Dose Expansion 3C: Third-line (3L) colorectal cancerExperimental

CR-001 in combination with trifluridine + tipiracil

CR-001 Dose Expansion 3D: First-line (1L) endometrial carcinomaExperimental

CR-001 in combination with paclitaxel + carboplatin

CR-001 Dose Expansion 3E: First-line (1L) gastric/gastroesophageal cancerExperimental

CR-001 in combination capecitabine + oxaliplatin

CR-001 Dose Expansion 3F: Second-line (2L) gastric/gastroesophageal cancerExperimental

CR-001 in combination with paclitaxel

CR-001 Dose Expansion 3G: First-line (1L) Biliary tract cancerExperimental

CR-001 in combination with gemcitabine + cisplatin

CR-001 Dose Optimization Cohort XExperimental

monotherapy dose level (DL)-X Indication-specific cohort populations will be tested

CR-001 Dose Optimization Cohort YExperimental

monotherapy dose level (DL)-Y Indication-specific cohort populations will be tested

Drugs: CR-001, Paclitaxel, trifluridine and tipiracil, Pemetrexed, Carboplatin, Oxaliplatin, Gemcitabin, Cisplatin, Capecitabine, FOLFOX

Sites

34 sites in 9 countries

United States 15, South Korea 5, Spain 4, Italy 3, Romania 2, United Kingdom 2, Australia 1, France 1, Ireland 1