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

NCT07335497
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Phase
Phase 1/Phase 2
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Recruitment status
Recruiting
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Participants
540
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Lead sponsor
Crescent Biopharma, Inc.
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Start date
2026-02-17
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Number of sites
34
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Summary
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.
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Acronym
ASCEND
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Short title
CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
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Official title
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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1/Phase 2
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Study type
Interventional
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Completion date
2029-02-01
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First posted
2026-01-13
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Registry last updated
2026-10-20
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Primary completion date
2029-02-01
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Start date
2026-02-17
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Participants
540
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Participant count basis
Estimated
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Planned participants
540
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Protocol amendments
2
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Number of sites
34
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Crescent Biopharma, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07335497
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ClinicalTrials.gov ID
NCT07335497
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Part 1 (Dose Escalation) - Incidence and nature of dose-limiting toxicities

    Timeframe: From the first dose of study drug up until approximately 1 month

    Per cohort

  2. 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

    Per Cohort

  3. 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

    Events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)

  4. 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

  5. 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

  6. 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

  1. All parts - Determination of recommended Phase 2 dose(s)

    Timeframe: From the first dose of study drug until 90 days after the last dose of study drug

  2. All parts - Serum CR-001 pharmacokinetic parameters

    Timeframe: Predose until up to approximately 36 months

    AUC0--inf after a single dose and steady state parameters, as appropriate

  3. All parts - Serum CR-001 pharmacokinetic parameters

    Timeframe: Predose until up to approximately 36 months

    AUClast after a single dose and steady state parameters, as appropriate

  4. All parts - Serum CR-001 pharmacokinetic parameters

    Timeframe: Predose until up to approximately 36 months

    Cmax after a single dose and steady state parameters, as appropriate

  5. All parts - Serum CR-001 pharmacokinetic parameters

    Timeframe: Predose until up to approximately 36 months

    Tmax after a single dose and steady state parameters, as appropriate

  6. All parts - Serum CR-001 pharmacokinetic parameters

    Timeframe: Predose until up to approximately 36 months

    Vd after a single dose and steady state parameters, as appropriate

  7. All parts - Serum CR-001 pharmacokinetic parameters

    Timeframe: Predose until up to approximately 36 months

    CL after a single dose and steady state parameters, as appropriate

  8. All parts - Serum CR-001 pharmacokinetic parameters

    Timeframe: Predose until up to approximately 36 months

    t½ after a single dose and steady state parameters, as appropriate

  9. All parts - Incidence of participants with detectable antidrug antibodies

    Timeframe: Predose until up to approximately 36 months

  10. Parts 1, 2 and 4 - Overall response rate

    Timeframe: From the first dose of study drug until up to approximately 36 months

  11. Parts 1, 2 and 4 - Duration of response

    Timeframe: From the first dose of study drug until up to approximately 36 months

  12. Parts 1, 2 and 4 - Time to response

    Timeframe: From the first dose of study drug until up to approximately 36 months

  13. Parts 1, 2 and 4 - Progression free survival

    Timeframe: From the first dose of study drug until up to approximately 36 months

  14. Parts 1, 2 and 4 - Overall survival

    Timeframe: From the first dose of study drug until up to approximately 36 months

  15. Parts 1, 2 and 4 - Best percent change in target lesions

    Timeframe: From the first dose of study drug until up to approximately 36 months

  16. Part 3 (Dose Expansion) - DOR, DCR, TTR, PFS, OS, and best percentage change in target lesions

    Timeframe: From the first dose of study drug until up to approximately 36 months

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

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 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:

    • Non-small cell lung cancer (NSCLC)
    • Hepatocellular carcinoma (HCC)
    • Biliary tract cancer (BTC)
    • Endometrial carcinoma
    • Cervical cancer
    • Ovarian cancer
    • Gastric or gastroesophageal cancer (GC/GEJ)
    • Colorectal cancer (CRC)

  • For dose expansion: have one of the following locally advanced or metastatic tumor types:

    • 1L Non-small cell lung cancer (NSCLC)
    • 1L Colorectal cancer (CRC)
    • 3L Colorectal cancer (CRC)
    • 1L Endometrial carcinoma
    • 1L Gastric or gastroesophageal cancer (GC/GEJ)
    • 2L Gastric or gastroesophageal cancer (GC/GEJ)
    • 1L Biliary tract cancer (BTC)

Key Exclusion Criteria for all parts

  • 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

Key Exclusion Criteria for dose expansion only

  • Has received prior anti-PD-1/L1 treatment
  • Has history of hypersensitivity reaction to the cohort-specific combination agent(s) or its excipients
  • Has any contraindication to the cohort-specific combination agent(s)
  • Has Grade >1 neuropathy at Screening NOTE: Other protocol defined Inclusion and Exclusion criteria may apply.
Sources for eligibility
clinicaltrials.gov

  • Clinical Study SiteBirmingham, United StatesRecruiting
  • Clinical Study SiteLos Angeles, United StatesRecruiting
  • Clinical Study SiteDenver, United StatesRecruiting
  • Clinical Study SiteWashington D.C., United StatesRecruiting
  • Clinical Study SiteOrlando, United StatesRecruiting
  • Clinical Study SiteSarasota, United StatesRecruiting
  • Clinical Study SiteDetroit, United StatesRecruiting
  • Clinical Study SiteGrand Rapids, United StatesRecruiting
  • Clinical Study SiteNew York, United StatesRecruiting
  • Clinical Study SiteColumbus, United StatesRecruiting
  • Clinical Study SitePittsburgh, United StatesRecruiting
  • Clinical Study SiteNashville, United StatesRecruiting
  • Clinical Study SiteDallas, United StatesRecruiting
  • Clinical Study SiteSan Antonio, United StatesRecruiting
  • Clinical Study SiteWest Valley City, United StatesRecruiting
  • Clinical Study SiteSouth Brisbane, AustraliaWithdrawn
  • Clinical Study SiteVillejuif, FranceRecruiting
  • Clinical Study SiteDublin, IrelandRecruiting
  • Clinical Study SiteCandiolo, ItalyRecruiting
  • Clinical Study SiteFlorence, ItalyRecruiting
  • Clinical Study SiteMilan, ItalyRecruiting
  • Clinical Study SiteCluj-Napoca, RomaniaRecruiting
  • Clinical Study SiteBucharest, RomaniaRecruiting
  • Clinical Study SiteSongpa-dong, South KoreaRecruiting
  • Clinical Study SiteSeongnam-si, South KoreaRecruiting

And 9 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-523590-42-00
Sources for references
clinicaltrials.gov

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