Locally Advanced / Metastatic Solid TumorsPhase 1/2ASCENDNCT07335497
CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
A Phase 1/2 study testing CR-001, Paclitaxel and trifluridine and tipiracil in people with Locally Advanced / Metastatic Solid Tumors, run by Crescent Biopharma, Inc. at 34 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced / Metastatic Solid Tumors
- What is being tested?
- CR-001, Paclitaxel and trifluridine and tipiracil
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 34 sitesin 9 countries
- Study dates
- 17 Feb 2026to Feb 2029
- Phase
- Phase 1/2
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
- 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:
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- 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)
Who cannot join
- 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)
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- 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
- 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.
Trial locations and contacts
34 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
34 sites in 9 countries
United States15 sites, 15 recruiting
- Recruiting
Clinical Study Site
Birmingham, Alabama, 35294
- Recruiting
Clinical Study Site
Columbus, Ohio, 43210
- Recruiting
Clinical Study Site
Dallas, Texas, 75230
- Recruiting
Clinical Study Site
Denver, Colorado, 80218
- Recruiting
Clinical Study Site
Detroit, Michigan, 48201
- Recruiting
Clinical Study Site
Grand Rapids, Michigan, 49546
- Recruiting
Clinical Study Site
Los Angeles, California, 90033
- Recruiting
Clinical Study Site
Nashville, Tennessee, 37203
- Recruiting
Clinical Study Site
New York, New York, 10029
- Recruiting
Clinical Study Site
Orlando, Florida, 32827
- Recruiting
Clinical Study Site
Pittsburgh, Pennsylvania, 15232
- Recruiting
Clinical Study Site
San Antonio, Texas, 78229
- Recruiting
Clinical Study Site
Sarasota, Florida, 34236
- Recruiting
Clinical Study Site
Washington D.C., District of Columbia, 20009
- Recruiting
Clinical Study Site
West Valley City, Utah, 84119
South Korea5 sites, 5 recruiting
- Recruiting
Clinical Study Site
Seongnam-si, 13620
- Recruiting
Clinical Study Site
Seoul, 03080
- Recruiting
Clinical Study Site
Seoul, 03722
- Recruiting
Clinical Study Site
Seoul, 06351
- Recruiting
Clinical Study Site
Songpa-dong, Seoul, 05505
Spain4 sites, 4 recruiting
- Recruiting
Clinical Study Site
Barcelona, 08023
- Recruiting
Clinical Study Site
Logroño, La Rioja, 26006
- Recruiting
Clinical Study Site
Madrid, 28040
- Recruiting
Clinical Study Site
Madrid, 28223
Italy3 sites, 3 recruiting
- Recruiting
Clinical Study Site
Candiolo, Torino, 10060
- Recruiting
Clinical Study Site
Florence, 50134
- Recruiting
Clinical Study Site
Milan, 20089
Romania2 sites, 2 recruiting
- Recruiting
Clinical Study Site
Bucharest, 022328
- Recruiting
Clinical Study Site
Cluj-Napoca, Cluj, 400015
United Kingdom2 sites, 2 recruiting
- Recruiting
Clinical Study Site
London, SE1 2PR
- Recruiting
Clinical Study Site
Manchester, Greater Manchester, M20 4 BX
Australia1 site
- Withdrawn
Clinical Study Site
South Brisbane, Queensland, 4101
About this study
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
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.
Read the detailed description
The study will be 4 parts: dose escalation, backfill, dose expansion and dose optimization cohorts. The study will follow a stepwise approach, beginning with a typical dose escalation in participants with selected indications of advanced solid tumors. Additional participants will enroll in the backfill part at select dose levels that have been previously cleared for safety by the safety review committee. Dose expansion will enroll 7 cohorts of participants who will receive CR-001 in combination with chemotherapy. In dose optimization, participants will be randomized to one of two CR-001 dose levels.
All participants will undergo a screening period, a treatment period of up to 2 years, a safety follow-up period, and long-term efficacy and survival follow-up. During the treatment period, participants will undergo clinical and safety assessments including disease assessment scans and blood laboratory safety, pharmacokinetic, and pharmacodynamic 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-001, Paclitaxel, trifluridine and tipiracil, Pemetrexed, Carboplatin
- Keywords
- solid tumors, metastatic, VEGF, PD-1, anti-PD-1, anti VEGF, immuno-oncology, anti-angiogenic therapy, checkpoint inhibitor, metastatic cancer, advanced cancer, First-in-Human, Dose Escalation, Dose Optimization
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CR-001Drug
Intravenous Infusion
PaclitaxelDrug
Intravenous Infusion
trifluridine and tipiracilDrug
Oral
PemetrexedDrug
Intravenous Infusion
CarboplatinDrug
Intravenous Infusion
OxaliplatinDrug
Intravenous Infusion
GemcitabinDrug
Intravenous Infusion
CisplatinDrug
Intravenous Infusion
CapecitabineDrug
Oral
FOLFOXDrug
Intravenous Infusion + Oral
| Study group | Role | What they receive |
|---|---|---|
| CR-001 Dose escalation | Experimental | 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 Receives: Drug: CR-001 |
| CR-001 Backfill | Experimental | Escalating dose levels of CR-001 Indication-specific cohort populations will be tested Receives: Drug: CR-001 |
| CR-001 Dose Expansion 3A: First-line (1L) Non-small cell lung cancer | Experimental | CR-001 in combination with paclitaxel or pemetrexed + carboplatin Receives: Drug: CR-001; Drug: Paclitaxel; Drug: Pemetrexed; Drug: Carboplatin |
| CR-001 Dose Expansion 3B: First-line (1L) colorectal cancer | Experimental | CR-001 in combination with FOLFOX Receives: Drug: CR-001; Drug: FOLFOX |
| CR-001 Dose Expansion 3C: Third-line (3L) colorectal cancer | Experimental | CR-001 in combination with trifluridine + tipiracil Receives: Drug: CR-001; Drug: trifluridine and tipiracil |
| CR-001 Dose Expansion 3D: First-line (1L) endometrial carcinoma | Experimental | CR-001 in combination with paclitaxel + carboplatin Receives: Drug: CR-001; Drug: Paclitaxel; Drug: Carboplatin |
| CR-001 Dose Expansion 3E: First-line (1L) gastric/gastroesophageal cancer | Experimental | CR-001 in combination capecitabine + oxaliplatin Receives: Drug: CR-001; Drug: Oxaliplatin; Drug: Capecitabine |
| CR-001 Dose Expansion 3F: Second-line (2L) gastric/gastroesophageal cancer | Experimental | CR-001 in combination with paclitaxel Receives: Drug: CR-001; Drug: Paclitaxel |
| CR-001 Dose Expansion 3G: First-line (1L) Biliary tract cancer | Experimental | CR-001 in combination with gemcitabine + cisplatin Receives: Drug: CR-001; Drug: Gemcitabin; Drug: Cisplatin |
| CR-001 Dose Optimization Cohort X | Experimental | monotherapy dose level (DL)-X Indication-specific cohort populations will be tested Receives: Drug: CR-001 |
| CR-001 Dose Optimization Cohort Y | Experimental | monotherapy dose level (DL)-Y Indication-specific cohort populations will be tested Receives: Drug: CR-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
All parts - Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and treatment - emergent serious adverse events
Events graded according to National Cancer Institute Common 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
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
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
Part 3 (Dose Expansion) - Overall response rate (ORR) by Investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Measured: From the first dose of study drug until 90 days after the last dose of study drug
Secondary outcomes (16)
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
All parts - Serum CR-001 pharmacokinetic parameters
AUC0--inf after a single dose and steady state parameters, as appropriate
Measured: Predose until up to approximately 36 months
All parts - Serum CR-001 pharmacokinetic parameters
AUClast after a single dose and steady state parameters, as appropriate
Measured: Predose until up to approximately 36 months
All parts - Serum CR-001 pharmacokinetic parameters
Cmax after a single dose and steady state parameters, as appropriate
Measured: Predose until up to approximately 36 months
All parts - Serum CR-001 pharmacokinetic parameters
Tmax after a single dose and steady state parameters, as appropriate
Measured: Predose until up to approximately 36 months
All parts - Serum CR-001 pharmacokinetic parameters
Vd after a single dose and steady state parameters, as appropriate
Measured: Predose until up to approximately 36 months
All parts - Serum CR-001 pharmacokinetic parameters
CL after a single dose and steady state parameters, as appropriate
Measured: Predose until up to approximately 36 months
All parts - Serum CR-001 pharmacokinetic parameters
t½ after a single dose and steady state parameters, as appropriate
Measured: Predose until up to approximately 36 months
All parts - Incidence of participants with detectable antidrug antibodies
Measured: Predose until up to approximately 36 months
Parts 1, 2 and 4 - Overall response rate
Measured: From the first dose of study drug until up to approximately 36 months
Parts 1, 2 and 4 - Duration of response
Measured: From the first dose of study drug until up to approximately 36 months
Parts 1, 2 and 4 - Time to response
Measured: From the first dose of study drug until up to approximately 36 months
Parts 1, 2 and 4 - Progression free survival
Measured: From the first dose of study drug until up to approximately 36 months
Parts 1, 2 and 4 - Overall survival
Measured: From the first dose of study drug until up to approximately 36 months
Parts 1, 2 and 4 - Best percent change in target lesions
Measured: From the first dose of study drug until up to approximately 36 months
Part 3 (Dose Expansion) - DOR, DCR, TTR, PFS, OS, and best percentage change in target lesions
Measured: From the first dose of study drug 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.
- First posted13 Jan 2026
- Study start17 Feb 2026
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced / Metastatic Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Crescent Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brad Sumrow, MD, Study director, Crescent Biopharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335497
- Sponsor's protocol ID
- CR-001-101
- Other IDs
- 2025-523590-42-00, 2025
- Acronym
- ASCEND
- Status last verified
- Oct 2026
- First submitted
- 8 Jan 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No