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

NCT07056777 | Recruiting Phase 1

• 1 other identifier: DR30206102
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastrointestinal Cancer

Keywords

Gastrointestinal Cancer

Outcome Measures

Primary Outcomes (6)

• 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.

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

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

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

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

• Phase Ib: Maximum tolerated dose(MTD)

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

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

• Phase Ib: Recommended phase 2 dose (RP2D)

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

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

• 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

  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)

• 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

  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

Study Arms (3)

DR30206+Oxaliplatin+Capecitabine

EXPERIMENTAL

DR30206 20mpk Q3W or DR30206 30mpk Q3W; Oxaliplatin 130 mg/m2, d1, Q3W; Capecitabine 1000 mg/m2, bid, d1-14, Q3W;

Drug: DR30206; Drug: Oxaliplatin; Drug: Capecitabine

DR30206+Oxaliplatin+Calcium Folinate+5-FU

EXPERIMENTAL

DR30206 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.

Drug: DR30206; Drug: Oxaliplatin; Drug: Calcium Folinate; Drug: 5-FU

DR30206+Irinotecan+Calcium Folinate+5-FU

EXPERIMENTAL

DR30206 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.

Drug: DR30206; Drug: Calcium Folinate; Drug: 5-FU; Drug: Irinotecan (CPT-11)

Interventions

DR30206 DRUG

Subjects receive DR30206 intravenously

DR30206+Irinotecan+Calcium Folinate+5-FU; DR30206+Oxaliplatin+Calcium Folinate+5-FU; DR30206+Oxaliplatin+Capecitabine

Oxaliplatin DRUG

Subjects receive Oxaliplatin intravenously

DR30206+Oxaliplatin+Calcium Folinate+5-FU; DR30206+Oxaliplatin+Capecitabine

Calcium Folinate DRUG

Subjects receive Calcium Folinate intravenously

DR30206+Irinotecan+Calcium Folinate+5-FU; DR30206+Oxaliplatin+Calcium Folinate+5-FU

Capecitabine DRUG

Subjects take Capecitabine orally

DR30206+Oxaliplatin+Capecitabine

5-FU DRUG

Subjects receive 5-FU by Intravenous Bolus

DR30206+Irinotecan+Calcium Folinate+5-FU; DR30206+Oxaliplatin+Calcium Folinate+5-FU

Irinotecan (CPT-11) DRUG

Subjects receive Irinotecan intravenously

DR30206+Irinotecan+Calcium Folinate+5-FU

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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;
• 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).

Sponsors & Collaborators

• Zhejiang Doer Biologics Co., Ltd.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

Oxaliplatin; Capecitabine; Leucovorin; Fluorouracil; Irinotecan

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Camptothecin; Alkaloids

Study Officials

• Yanshan Huang CEO

  Zhejiang Doer Biologics Co., Ltd.

  STUDY CHAIR

• Ruihua Xu

  Sun Yat-Sen University Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yulong Gan Clinical Operations Director

CONTACT

+8615194402868; yg@doerbio.com

Yongliang Fang Chief Operating Officer

CONTACT

+86057128256206; yf@doerbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 9, 2025
• Study Start: March 25, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

CN (1)