Evaluate the Safety, Tolerability, Pharmacokinetics of DR30206 in Patients With Advanced or Metastatic Solid Tumors

NCT06132828 | Recruiting Phase 1

• 1 other identifier: DR30206101
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to characterize the safety,tolerability, pharmacokinetics(PK),and preliminary anti-tumor activity of DR30206, in subjects with advanced or metastatic solid tumors

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (7)

• PartA: 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 following first dose

• PartA: Maximum tolerated dose (MTD)

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

  21 days following first dose

• PartA: Recommend dose of expansion(RDE)

  A Recommend dose of expansion will be determined based on safety data

  21 days following first dose

• PartA+B: Adverse evens (AEs)

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

  Up to 90 days after last dose

• PartA+B: Serious adverse evens (SAEs)

  A Serious Adverse Event (SAE) is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect

  Up to 90 days after last dose

• PartB: Objective response rate (ORR)

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

  Up to approximately 12 months

• PartB: Recommended phase 2 dose (RP2D)

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

  21 days following first dose

Study Arms (2)

DR30206

EXPERIMENTAL

Subjects receive DR30206 monotherapy intravenously(IV) until no more benefits from treatment.

Drug: DR30206

Phase Ib: DR30206

EXPERIMENTAL

The non-small cell lung cancer subjects receive DR30206 (30mpk,Q3W) monotherapy intravenously(IV) until no more benefits from treatment.

Drug: DR30206

Interventions

DR30206 DRUG

Subjects receive DR30206 intravenously

Also known as: DR30206 for Injection

DR30206; Phase Ib: DR30206

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
• Part A: Subjects with advanced or metastatic malignant solid tumors confirmed by histology or cytology who have failed or are intolerant to standard therapy or have no effective standard therapy
• Part B: The NSCLC cohort is planned to enroll patients with histologically or cytologically confirmed NSCLC who have locally advanced or metastatic NSCLC and are not eligible for curative treatment; patients must have no histologically confirmed EGFR-sensitive mutations or ALK gene fusions; they must not have received prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC; and they must provide tumor tissue samples (approximately 5 unstained slides) obtained at the time of or after diagnosis of locally advanced or metastatic disease and within 2 years, without radiotherapy, which must be confirmed by the central laboratory to have tumor PD-L1 TPS ≥1%. Other potential cohorts may include patients with histologically or cytologically confirmed advanced or metastatic specific tumor types who have failed standard therapy, are intolerant to standard therapy, or have no effective standard therapy. These include, but are not limited to, cervical cancer, hepatocellular carcinoma, TNBC (Triple Negative Breast Cancer), and other tumor types such as gastric cancer, ovarian cancer, colorectal cancer, and tumor types with efficacy signals (CR/PR) identified during the dose escalation phase.
• Patients in part A must have at least one evaluable lesion, and in part B must have at least one measurable lesion according to RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0 or 1
• The expected survival period ≥3 months
• 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 6 months after the end of the last medication
• Be able to understand the procedures and methods of this study, and willing to strictly follow the clinical trial protocol to complete this study

You may not qualify if:

• Patients with a history of severe allergies to monoclonal antibodies (mAb) or bispecific antibodies, or known allergies to drug component of the study drug
• Patients with active malignant tumors within the past 2 years, except for the tumors participating in the study and locally cured tumors
• Severe chronic or active infections, including but not limited to hospitalization due to complications of infection, bacteremia, or severe pneumonia, or any active infection that the investigator believes may affect the safety of the subject, within 4 weeks prior to the start of the study treatment; Systemic antibiotic treatment within 2 weeks before starting the study treatment
• Received the following treatments or medications within 4 weeks before starting the study treatment: a. Interventional clinical studies; b. Major surgery or severe traumatic injury, or expected to require major surgery during the study process; c. 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; Systemic treatment with anti-tumor drugs, or local anti-tumor therapy, or treatment with systemic immune stimulators (including but not limited to interferon or interleukin-2 (IL-2)
• Radical radiotherapy within 3 months before starting the study treatment
• Received systemic immunosuppressive medication treatment within 4 weeks prior to the start of the study, or is expected to require systemic immunosuppressive medication during the study treatment period
• Known active central nervous system (CNS) metastasis
• There have been clinically significant cardiovascular and cerebrovascular diseases within 6 months prior to the first study drug dosing
• Active stage of autoimmune disease or immune deficiency or history of autoimmune disease or immune deficiency
• Have a history of interstitial pneumonia, idiopathic pulmonary fibrosis, organized pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, idiopathic pneumonia, or evidence of active pneumonia found on screening chest CT scans; Previously used hormone therapy for pneumonia
• Active or previously diagnosed inflammatory bowel disease (such as Crohn's disease, ulcerative colitis)
• During the screening period, there were a large or symptomatic moderate amount of pleural effusion, pericardial effusion, and abdominal effusion
• During the screening period, imaging showed that the tumor were surrounded by important blood vessels or had obvious necrosis or cavities, and the investigators determined that enrolling into the study would pose a risk of bleeding
• Previous or current complications such as gastrointestinal perforation surgery, wound healing, and bleeding events
• Current or recent use of aspirin (\>325 mg/day) or treatment with clopidogrel, clopidogrel, and cilostazol (within 10 days prior to the first study drug dosing)

Sponsors & Collaborators

• Zhejiang Doer Biologics Co., Ltd.: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Caicun Zhou, MD

  Shanghai Pulmonary Hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

• Yanshan Huang, PhD

  Zhejiang Doer Biologics Co., Ltd.

  STUDY CHAIR

• Junfang Xu, MD

  Huadong Medicine Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Senior Clinical Operations Director

CONTACT

+86 151 94 40 28 68; yg@doerbio.com

Chief Operating Officer

CONTACT

+86 05 71 28 25 62 06; 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: November 10, 2023
• First Posted: November 15, 2023
• Study Start: November 27, 2023
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

CN (1)