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-001

Phase 1

Locally Advanced / Metastatic Solid Tumors | Small molecule | Oncology |Crescent Biopharma, Inc.|Last Updated: May 28, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment290
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07335497CR-001 in Adult Participants With Locally Advanced or Metastatic Solid TumorsPHASE1 RECRUITING 290 — — Feb 17, 2026Feb 1, 2029May 28, 202612 United States, Australia +1
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Study Endpoints
Primary Endpoints
Dose Escalation - Incidence and nature of dose-limiting toxicities
From the first dose of study drug up until approximately 1 month

Per cohort

Dose Escalation - Characterization of the maximum tolerated dose, if applicable
From the first dose of study drug up until approximately 1 month

Per Cohort

All parts - Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and treatment - emergent serious adverse events
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)

All parts - Incidence and severity of TEAEs leading to dose modifications
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
From the first dose of study drug until 90 days after the last dose of study drug
Secondary Endpoints
All parts - Determination of recommended Phase 2 dose(s)
From the first dose of study drug until 90 days after the last dose of study drug
All parts - Serum CR-001 pharmacokinetic parameters
Predose until up to approximately 36 months
All parts - Incidence of participants with detectable antidrug antibodies
Predose until up to approximately 36 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CR-001 Dose escalationEXPERIMENTALEscalating 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 BackfillEXPERIMENTALEscalating dose levels of CR-001 Indication-specific cohort populations will be tested
CR-001 Dose Optimization Cohort XEXPERIMENTALmonotherapy dose level (DL)-X Indication-specific cohort populations will be tested
CR-001 Dose Optimization Cohort YEXPERIMENTALmonotherapy DL-Y Indication-specific cohort populations will be tested
Interventions
NameTypeDescription
CR-001DRUGIntravenous Infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites12

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: W...

Countries:United StatesAustraliaSouth Korea
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Recent Changes (Last 90 Days)
LOWMay 29, 2026NCT07335497lastUpdatePostDate: changed
LOWMay 29, 2026NCT07335497lastUpdatePostDate: changed
LOWMay 29, 2026NCT07335497lastUpdatePostDate: changed
LOWMay 26, 2026NCT07335497primaryCompletionDate: changed
LOWMay 24, 2026NCT07335497studyFirstPostDate: changed