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Gastrointestinal CancerPhase 1/2NCT07056777

Evaluation of the Preliminary Efficacy and Safety of DR30206 in Combination With Standard Therapy in Patients With Gastrointestinal Cancer

A Phase 1/2 study testing DR30206, Oxaliplatin and Capecitabine in people with Gastrointestinal Cancer, run by Zhejiang Doer Biologics Co., Ltd. at 1 site in China.

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

This is a multicenter, open-label phase Ib/IIa clinical study conducted in China, aimed at evaluating the safety tolerance, efficacy, pharmacokinetic (PK) characteristics, and immunogenicity of DR30206 in combination with standard treatment regimens for advanced or metastatic gastrointestinal tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastrointestinal Cancer
What is being tested?
DR30206, Oxaliplatin and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
186 participants
Where
1 siteChina
Study dates
25 Mar 2025to 30 Jun 2027
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily sign a written informed consent form.
  • Patients must be ≥ 18 and ≤75 years of age.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Expected survival period of at least 3 months.
  • Depending on the tumor type, subjects must meet the following respective requirements:
  • Colorectal cancer: i. Histologically or cytologically confirmed unresectable locally advanced or metastatic colorectal cancer; ii. Subjects who have not previously received systemic chemotherapy(except for left-sided colorectal cancer with wild-type RAS/BRAF); or subjects who have progressed after first-line chemotherapy with or without targeted or immunotherapy.
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  • Other gastrointestinal tumors: i. Histologically or cytologically confirmed unresectable locally advanced or metastatic esophageal adenocarcinoma, gastric adenocarcinoma, or gastroesophageal junction adenocarcinoma, with HER2-negative or low expression; ii. Subjects who have not previously received systemic chemotherapy; for patients who previously received adjuvant chemotherapy, neoadjuvant chemotherapy, or radical chemoradiotherapy for advanced disease with curative intent, if disease progression occurs more than 6 months after the completion of the last treatment, they are eligible for this study.
  • According to RECIST v1.1, subjects must have at least one measurable lesion.
  • Adequate bone marrow, liver, and renal function.
  • Male or female subjects with fertility must agree to take effective contraceptive measures during the study period and within 180 days after the end of the last medication.
  • Able to understand and follow the scheduled visits, treatments, laboratory tests, and other study procedures.

Who cannot join

  • Subjects with MSI-H or dMMR.
  • A history of severe allergic reactions to other monoclonal antibodies (mAb) or bispecific antibodies, or known allergies to any investigational drug or its components in this study.
  • Use of high-dose corticosteroids (>10 mg/day prednisone or equivalent doses of other corticosteroids) or other immunosuppressive drugs within 14 days prior to the first administration of the investigational drug.
  • Received the following treatments or medications within 28 days before starting the study treatment: a. Inoculate live attenuated vaccines, or expect to receive such vaccines during the study treatment period or within 5 months after the last administration of the study treatment; b.Systemic treatment with anti-tumor drugs, or local anti-tumor therapy.
  • Received local radiotherapy within 2 months prior to the first administration of investigational drug (palliative radiotherapy for bone metastasis completed more than 2 weeks before baseline tumor assessment is acceptable);
  • Received non-specific immunomodulatory therapy (e.g., interleukins, interferons, thymosin, tumor necrosis factor, etc.) within 2 weeks prior to the first administration of investigational drug;
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  • Receipt of other investigational drugs or investigational medical devices within 28 days prior to the first administration of the investigational drug.
  • Major surgery (defined as requiring general anesthesia and hospitalization for more than 24 hours) or severe traumatic injury within 28 days prior to the first administration of the investigational drug, or expected to require major surgery during the study period, except for minor procedures (e.g., tooth extraction, biopsy) deemed not to affect participation in the study by the investigator.
  • Presence of severe chronic or active infections within 28 days prior to the first administration of the investigational drug, including but not limited to hospitalization for infection, sepsis, or severe pneumonia complications, or any active infection that the investigator considers may affect the participant's safety; or systemic antibiotic therapy within 2 weeks prior to the start of treatment (routine prophylactic anti-infective therapy is exempt).
  • Persistent clinically significant toxicities (CTCAE 5.0 Grade 2 or higher, e.g., hyperpigmentation, alopecia, etc.), except for adverse reactions deemed to have no safety risk by the investigator, related to prior treatments (including systemic therapy, radiotherapy, or surgery).
  • Presence of central nervous system (CNS) metastases and/or cancerous meningitis. Subjects who have received local treatment for brain metastases may be considered for participation in this study provided that imaging confirms no disease progression within 4 weeks prior to the first administration of the investigational drug, all neurological symptoms are stable, there is no evidence of new or enlarging CNS metastases, and radiotherapy, surgery, or corticosteroid therapy for CNS metastases has been discontinued for at least 28 days prior to the first administration of the investigational drug. However, cancerous meningitis, regardless of clinical stability, should be excluded.
  • Hepatitis B virus infection (must meet both HBsAg positive and HBV-DNA > 500 IU/mL), Hepatitis C virus infection (must meet both HCV-Ab positive and HCV-RNA positive), Human Immunodeficiency virus infection (HIV-Ab positive), active syphilis infection, active tuberculosis infection.
  • There have been clinically significant cardiovascular and cerebrovascular diseases within 6 months prior to the first study drug dosing.
  • Within 2 years prior to the first administration of the investigational drug, the subject has active autoimmune diseases requiring systemic treatment (e.g., use of glucocorticoids or immunosuppressive drugs). Replacement therapies (e.g., levothyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency) are permitted.
  • Within 3 years prior to the first administration of the investigational drug, the subject has a history of other malignancies, except those cured by definitive treatment with expectation of cure, such as basal or squamous cell skin cancer, localized low-risk prostate cancer, papillary thyroid cancer, or any in situ cancer treated by definitive resection (e.g., cervical intraepithelial neoplasia, ductal carcinoma in situ).
  • The subjects have other severe or uncontrolled medical conditions, or the investigator deems the subject unsuitable for participation in this clinical trial or believes it would affect the subject's adherence to the study protocol, including but not limited to: a) History of or current concomitant severe respiratory diseases; b) Severe arterial or venous thromboembolic events within 6 months prior to the first investigational drug administration; c) Massive pleural effusion, ascites, or pericardial effusion with clinical symptoms or requiring symptomatic treatment within 28 days prior to the first investigational drug administration; d) Active or history of inflammatory bowel disease; e) History of severe peptic ulcer, gastrointestinal perforation, fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding, or esophageal or gastric variceal bleeding due to portal hypertension within 6 months prior to the first investigational drug administration; f) History of clinically significant bleeding symptoms within 1 month prior to the first study drug administration; g) Imaging at screening shows tumor encasement of major vessels or presence of significant necrosis or cavitation, and the investigator judges that enrollment would increase the risk of bleeding.
  • The subject has a history of allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
  • The subject has a history of substance abuse or a mental disorder that may affect compliance with the study.
  • Pregnant or breastfeeding women, where pregnancy is defined as the period from conception until the termination of pregnancy, and confirmed by a laboratory human chorionic gonadotropin (hCG) test within 7 days prior to the start of the study.
  • Other conditions deemed unsuitable for participation in this study by the investigator.

Trial locations and contacts

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

Yulong Gan Clinical Operations Director contact

+8615194402868

yg@doerbio.com

Yongliang Fang Chief Operating Officer contact

+86057128256206

yf@doerbio.com

China1 site, 1 recruiting
  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Ruihua Xu Principal Investigator, 020-87343468, ruihxu@163.com

    Recruiting

Other trials in China

About this study

Official title: A Phase Ib/IIa Clinical Trial Evaluating the Preliminary Efficacy and Safety of DR30206 in Combination With Standard Therapy in Patients With Gastrointestinal Tumors

This is a multicenter, open-label phase Ib/IIa clinical study conducted in China, aimed at evaluating the safety tolerance, efficacy, pharmacokinetic (PK) characteristics, and immunogenicity of DR30206 in combination with standard treatment regimens for advanced or metastatic gastrointestinal tumors.

Read the detailed description

This is a multicenter, open-label phase Ib/IIa clinical study conducted in China, aimed at evaluating the safety tolerance, efficacy, pharmacokinetic (PK) characteristics, and immunogenicity of DR30206 in combination with standard treatment regimens for advanced or metastatic gastrointestinal tumors.

The study consists of two phases: the dose escalation phase (phase Ib) and the dose expansion phase (phase IIa). Based on the tumor type and treatment approach of the participants, different cohorts are established within both the phases Ib and IIa.

Being tested
DR30206, Oxaliplatin, Capecitabine, Calcium Folinate, 5-FU
Keywords
Gastrointestinal Cancer
Medical subject headings
Gastrointestinal Neoplasms

What participants receive

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

  • DR30206Drug

    Subjects receive DR30206 intravenously

  • OxaliplatinDrug

    Subjects receive Oxaliplatin intravenously

  • CapecitabineDrug

    Subjects take Capecitabine orally

  • Calcium FolinateDrug

    Subjects receive Calcium Folinate intravenously

  • 5-FUDrug

    Subjects receive 5-FU by Intravenous Bolus

  • Irinotecan (CPT-11)Drug

    Subjects receive Irinotecan intravenously

Study groups in NCT07056777
Study groupRoleWhat they receive
DR30206+Oxaliplatin+CapecitabineExperimentalDR30206 20mpk Q3W or DR30206 30mpk Q3W; Oxaliplatin 130 mg/m2, d1, Q3W; Capecitabine 1000 mg/m2, bid, d1-14, Q3W;
Receives: Drug: DR30206; Drug: Oxaliplatin; Drug: Capecitabine
DR30206+Oxaliplatin+Calcium Folinate+5-FUExperimentalDR30206 15mpk Q2W or DR30206 20mpk Q2W; Oxaliplatin 85 mg/m2, d1, Q2W; Calcium Folinate 400mg/m2, d1, Q2W; 5-FU 400mg/m2, d1 and 5-FU 1200mg/m2, d2-3, Q2W.
Receives: Drug: DR30206; Drug: Oxaliplatin; Drug: Calcium Folinate; Drug: 5-FU
DR30206+Irinotecan+Calcium Folinate+5-FUExperimentalDR30206 15mpk Q2W or DR30206 20mpk Q2W; Irinotecan 180 mg/m2, d1, Q2W; Calcium Folinate 400mg/m2, d1, Q2W; 5-FU 400mg/m2, d1 and 5-FU 1200mg/m2, d2-3, Q2W.
Receives: Drug: DR30206; Drug: Calcium Folinate; Drug: 5-FU; Drug: Irinotecan (CPT-11)

What is being measured

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

  1. Phase Ib: Incidence of dose limiting toxicities (DLTs)

    Dose-limiting describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.

    Measured: 21 days or 28 days following first dose according to the arms.

  2. Phase Ib: Incidence and severity of treatment-emergent adverse events (TEAEs)

    The incidence and severity of AEs graded according to NCI-CTCAE v5.0.

    Measured: From the first dose up to 90 days after the last dose or initiation of new anti-tumor treatment

  3. Phase Ib: Maximum tolerated dose(MTD)

    As measured by number of participants experiencing dose related toxicity (DLT) in each escalating cohort.

    Measured: 21 days or 28 days following first dose according to the arms.

  4. Phase Ib: Recommended phase 2 dose (RP2D)

    A recommended phase 2 dose will be determined based on safety data.

    Measured: 21 days or 28 days following first dose according to the arms.

  5. Phase IIa: Objective response rate (ORR) (RECIST v1.1) of DR30206 in combination with standard therapy for the treatment of other gastrointestinal tumors

    Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1

    Measured: the period from the date of initial medication to the objective recording of disease progression according to RECIST 1.1 standards or to the start of new anti-tumor treatment (whichever occurs first)

  6. Phase IIa: Objective response rate (ORR) (RECIST v1.1) of DR30206 in combination with standard therapy for the treatment of advanced or metastatic colorectal cancer.

    Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1

    Measured: the period from the date of initial medication to the objective recording of disease progression according to RECIST 1.1 standards or to the start of new anti-tumor treatment (whichever occurs first), assessed up to 24 months

Timeline

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

  1. First posted9 Jul 2025
  2. Study start25 Mar 2025
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Jun 2027 (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
Single group
Masking
None (open label)
Enrolment
186 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07056777
Sponsor's protocol ID
DR30206102
Status last verified
Jun 2026
First submitted
29 Jun 2025
Last updated
30 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing DR30206, Oxaliplatin and Capecitabine in people with Gastrointestinal Cancer, run by Zhejiang Doer Biologics Co., Ltd. at 1 site in China.

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 11 inclusion and 20 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 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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 Yulong Gan Clinical Operations Director (+8615194402868, yg@doerbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase Ib: Incidence of dose limiting toxicities (DLTs) (time frame: 21 days or 28 days following first dose according to the arms.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 30 Jun 2026.

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