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001

Phase 1

Locally Advanced / Metastatic Solid Tumors | Small molecule | Oncology |Crescent Biopharma, Inc.|Last Updated: Aug 14, 2026

Target and mechanism

Molecular targetPD-1
Target classProtein
ModalitySmall molecule

Also known as CR-001

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment290

FDA Designations

No designations recorded

Clinical trial landscape

001 · 1 trial · 1 indication

Phase 1 1
NCT07335497CR-001 in Adult Participants With Locally Advanced or Metastatic Solid TumorsLocally Advanced / Metastatic Solid Tumors
RECRUITING290 Analytics
PHASE1RECRUITING
CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Locally Advanced / Metastatic Solid TumorsUnlock trial analytics

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 to N/A
SexALL
Healthy VolunteersNo
Study Sites28

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 StatesAustraliaIrelandItalyRomaniaSouth KoreaSpain
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Recent Changes (Last 90 Days)

LOWAug 14, 2026NCT07335497lastUpdatePostDate: changed
LOWAug 14, 2026NCT07335497lastUpdatePostDate: changed
LOWJul 29, 2026NCT07335497lastUpdatePostDate: changed
LOWJul 29, 2026NCT07335497lastUpdatePostDate: changed
LOWJul 21, 2026NCT07335497lastUpdatePostDate: changed
LOWJul 13, 2026NCT07335497lastUpdatePostDate: changed
LOWJul 13, 2026NCT07335497lastUpdatePostDate: changed
LOWJun 29, 2026NCT07335497lastUpdatePostDate: changed
LOWJun 29, 2026NCT07335497lastUpdatePostDate: changed
LOWJun 23, 2026NCT07335497lastUpdatePostDate: changed
LOWJun 23, 2026NCT07335497lastUpdatePostDate: changed
LOWJun 16, 2026NCT07335497lastUpdatePostDate: changed
LOWJun 16, 2026NCT07335497lastUpdatePostDate: changed
LOWJun 16, 2026NCT07335497lastUpdatePostDate: changed
LOWMay 29, 2026NCT07335497lastUpdatePostDate: changed
LOWMay 29, 2026NCT07335497lastUpdatePostDate: changed
LOWMay 29, 2026NCT07335497lastUpdatePostDate: changed

Frequently asked questions about 001

What is CR-001 used for?

CR-001 is an investigational small molecule being developed for the treatment of locally advanced or metastatic solid tumors. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does CR-001 target?

CR-001 targets PD-1, a protein involved in immune checkpoint regulation. By targeting PD-1, CR-001 is designed to modulate the immune system's response to cancer cells, though its exact mechanism is still under investigation in clinical trials.

Who is developing CR-001?

CR-001 is being developed by Crescent Biopharma, Inc., a company traded under the ticker CBIO. The drug is currently in Phase 1 clinical trials for locally advanced or metastatic solid tumors.

What phase is CR-001 in?

CR-001 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is recruiting participants with locally advanced or metastatic solid tumors.

What clinical trials is CR-001 in?

CR-001 is being evaluated in a Phase 1 clinical trial with the identifier NCT07335497. This trial is recruiting adult participants with locally advanced or metastatic solid tumors and is being conducted in the United States, Australia, Ireland, Italy, Romania, South Korea, and Spain.

Is CR-001 the same as -001?

Yes, CR-001 is also known as -001. Both names refer to the same investigational drug being developed by Crescent Biopharma, Inc. for the treatment of locally advanced or metastatic solid tumors.