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Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M)Phase 1/2APOLLONCT07909031

CR-002 in Adult Participants With Locally Advanced or Metastatic Solid Tumors

A Phase 1/2 study testing CR-002 in people with Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M) and Gastric/GEJ, run by Crescent Biopharma, Inc. at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to determine the safety and tolerability of monotherapy CR-002 and to identify the MTD and/or optimal biologic dose and RP2D(s) in participants with locally advanced or metastatic solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CR-002
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
219 participants
Where
3 sitesUnited States
Study dates
21 Oct 2026to Jan 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Willingness to provide recent archival tumor tissue sample or willingness to undergo biopsy
  • Tumor indication specific inclusion criteria:
Show all 15Show fewer
  • Is 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:
  • Head and Neck Squamous Cell Carcinoma (HNSCC)
  • Gastric/GEJ Cancer
  • Biliary Tract Cancer (BTC)
  • Esophageal Squamous Cell Carcinoma (ESCC)
  • Ovarian Cancer
  • Endometrial Carcinoma
  • Cervical Cancer
  • Non-Small Cell Lung Cancer (NSCLC)

Who cannot join

  • Has malignancies other than disease under study within the past 3 years
  • Has not adequately recovered from recent major surgery
  • Has ongoing clinically significant toxicity related to prior therapy
  • Has known sensitivity to any component of CR-002
  • Has received prior treatment with an antibody-drug conjugate (ADC) with a topoisomerase I inhibitor payload.
  • Has active central nervous system (CNS) metastases
  • Has a medical or psychological condition that could interfere with study participation, increase risk, or affect interpretation of the study results
  • NOTE: Other protocol defined Inclusion and Exclusion criteria may apply.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Crescent Clinical Trials contact

617-430-5595

clinicaltrials@crescentbiopharma.com

United States3 sites, 3 recruiting

  • Clinical Study Site

    Austin, Texas, 78758

    Recruiting

  • Clinical Study Site

    Dallas, Texas, 75039

    Recruiting

  • Clinical Study Site

    Fairfax, Virginia, 22031

    Recruiting

Other trials in United States

About this study

Official title: A Phase 1/2, Multicenter, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of CR-002 in Adult Participants With Locally Advanced or Metastatic Solid Tumors

The purpose of this study is to determine the safety and tolerability of monotherapy CR-002 and to identify the MTD and/or optimal biologic dose and RP2D(s) in participants with locally advanced or metastatic solid tumors.

Read the detailed description

The study will initially comprise 2 parts: dose escalation (Part 1) and backfill (Part 2). Population-defined dose optimization (Part 3) and expansion (Part 4) cohorts may be added based on emerging data.

Part 1: The study will follow a stepwise approach, beginning with a typical dose escalation in participants with selected indications of advanced solid tumors.

Part 2: Additional participants will enroll in the backfill part at select dose levels that have been previously cleared for safety by the safety review committee.

All participants will undergo a screening period, a treatment period, a safety follow-up period, and long-term follow-up. During the treatment period, participants will undergo clinical and safety assessments including disease assessment scans and blood laboratory safety, and pharmacokinetic assessments. After treatment ends, disease scans will continue until disease progression, and long-term follow-up visits will be conducted by telephone every 3 months.

Being tested
CR-002
Keywords
Advanced Solid Tumors, Metastatic Solid Tumors, ADC
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Recurrence, Neoplasm Metastasis, Biliary Tract Neoplasms, Esophageal Squamous Cell Carcinoma, Ovarian Neoplasms, Endometrial Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CR-002Drug

    Intravenous Infusion

Study groups in NCT07909031
Study groupRoleWhat they receive
CR-002 Dose EscalationExperimentalEscalating dose levels of CR-002 will be tested to define the maximum tolerated dose of CR-002 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.
Receives: Drug: CR-002
CR-002 BackfillExperimentalEscalating dose levels of CR-002 will be tested in indication-specific cohort populations.
Receives: Drug: CR-002

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Dose Escalation - incidence and nature of dose-limiting toxicities

    Per cohort

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

  2. Part 1: Dose Escalation - characterization of the maximum tolerated dose, if applicable

    Per cohort

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

  3. All Parts - incidence, nature, and severity of treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events

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

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

  4. All Parts - incidence and severity of TEAEs leading to dose modifications

    Measured: 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

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

Secondary outcomes (17)

  1. All Parts - determination of recommended phase 2 dose(s)

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

  2. All Parts - serum CR-002 pharmacokinetic parameters

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

    Measured: Predose until up to approximately 36 months

  3. All Parts - serum CR-002 pharmacokinetic parameters

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

    Measured: Predose until up to approximately 36 months

  4. All Parts - serum CR-002 pharmacokinetic parameters

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

    Measured: Predose until up to approximately 36 months

  5. All Parts - serum CR-002 pharmacokinetic parameters

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

    Measured: Predose until up to approximately 36 months

  6. All Parts - serum CR-002 pharmacokinetic parameters

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

    Measured: Predose until up to approximately 36 months

  7. All Parts - serum CR-002 pharmacokinetic parameters

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

    Measured: Predose until up to approximately 36 months

  8. All Parts - serum CR-002 pharmacokinetic parameters

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

    Measured: Predose until up to approximately 36 months

  9. All Parts - incidence of participants with detectable antidrug antibodies

    Measured: Predose until up to approximately 36 months

  10. All Parts - overall response rate (ORR)

    Measured: Predose until up to approximately 36 months

  11. All Parts - duration of response (DOR)

    Measured: Predose until up to approximately 36 months

  12. All Parts - disease control rate (DCR)

    Measured: Predose until up to approximately 36 months

  13. All Parts - clinical benefit rate (CBR)

    Measured: Predose until up to approximately 36 months

  14. All Parts - time to response (TTR)

    Measured: Predose until up to approximately 36 months

  15. All Parts - progression free survival (PFS)

    Measured: Predose until up to approximately 36 months

  16. All Parts - overall survival (OS)

    Measured: Predose until up to approximately 36 months

  17. All Parts - best percent change in target lesions

    Measured: Predose until up to approximately 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2026
  2. Study start21 Oct 2026
  3. Primary completionOct 2028 (estimated)
  4. Study completionJan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
219 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07909031
Sponsor's protocol ID
CR-002-101
Other IDs
2026-527289-54-00
Acronym
APOLLO
Status last verified
Oct 2026
First submitted
20 Oct 2026
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CR-002 in people with Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M) and Gastric/GEJ, run by Crescent Biopharma, Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Crescent Clinical Trials (617-430-5595, clinicaltrials@crescentbiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Dose Escalation - incidence and nature of dose-limiting toxicities (time frame: From the first dose of study drug up until approximately 1 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07909031.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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