Solid TumorPhase 1NCT06132828
Evaluate the Safety, Tolerability, Pharmacokinetics of DR30206 in Patients With Advanced or Metastatic Solid Tumors
A Phase 1 study testing DR30206 in people with Solid Tumor, run by Zhejiang Doer Biologics Co., Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- DR30206
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteChina
- Study dates
- 27 Nov 2023to 30 Sep 2027
- Phase
- Phase 1
- 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
- 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
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- 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
Who cannot join
- 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
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- 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)
- Receiving full dose oral or parenteral anticoagulant or thrombolytic therapy, but still unstable for at least 2 weeks before the first study drug dosing
- Adverse reactions caused by previous treatment that have not recovered to CTCAE 5.0 level 1 or below (but pigmentation, hair loss, etc. can be included if the investigator deems that there is no safety risk)
- Known active infection
- The subject has previously received allogeneic stem cell or organ transplantation
- History of organ or hematopoietic stem cell transplantation that requires the use of immunosuppressants
- Pregnant or lactating women, defined as women in a state of pregnancy until termination of pregnancy, are determined by laboratory human chorionic gonadotropin (hCG) testing within 7 days prior to the start of the study
- Any other disease, medical condition or abnormality, metabolic dysfunction, alcohol or drug abuse or dependence, physical examination or lab testing results that potential impact on result interpretation or will increase the likelihood of complications for patients
- Participants who are not appropriate for this clinical trial at the discretion of 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.
China1 site, 1 recruiting
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Zhou Caicun, MD, +86 021 6511 5006, caicunzhoudr@126.com
About this study
Official title: A Multicenter, Open-Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics of DR30206 in Patients With Advanced or Metastatic Solid Tumors
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
Read the detailed description
This study is an open, phase I study to evaluate the safety, tolerability, pharmacokinetics of DR30206 in patients with advanced or metastatic solid tumors. The study is composed of two parts: part A is Dose escalation stage and part B is Dose expansion stage
- Conditions
- Solid Tumor
- Being tested
- DR30206
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DR30206Drug
Also called DR30206 for Injection
Subjects receive DR30206 intravenously
| Study group | Role | What they receive |
|---|---|---|
| DR30206 | Experimental | Subjects receive DR30206 monotherapy intravenously(IV) until no more benefits from treatment. Receives: 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. Receives: Drug: DR30206 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 21 days following first dose
PartA: Recommend dose of expansion(RDE)
A Recommend dose of expansion will be determined based on safety data
Measured: 21 days following first dose
PartA+B: Adverse evens (AEs)
The incidence and severity of AEs graded according to NCI-CTCAE v5.0
Measured: 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
Measured: 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
Measured: Up to approximately 12 months
PartB: Recommended phase 2 dose (RP2D)
A recommended phase 2 dose will be determined based on safety data
Measured: 21 days following first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start27 Nov 2023
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Doer Biologics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Caicun Zhou, MD, Principal investigator, Shanghai Pulmonary Hospital, Shanghai, ChinaYanshan Huang, PhD, Study chair, Zhejiang Doer Biologics Co., Ltd.Junfang Xu, MD, Study director, Huadong Medicine Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132828
- Sponsor's protocol ID
- DR30206101
- Status last verified
- Apr 2026
- First submitted
- 10 Nov 2023
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics of DR30206 in Patients With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06132828
- Acronym / sponsor ID
- DR30206101
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Zhejiang Doer Biologics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This study is an open, phase I study to evaluate the safety, tolerability, pharmacokinetics of DR30206 in patients with advanced or metastatic solid tumors. The study is composed of two parts: part A is Dose escalation stage and part B is Dose expansion stage
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DR30206 | Experimental | Drug: DR30206Subjects receive DR30206 monotherapy intravenously(IV) until no more benefits from treatment. |
| Phase Ib: DR30206 | Experimental | Drug: DR30206The non-small cell lung cancer subjects receive DR30206 (30mpk,Q3W) monotherapy intravenously(IV) until no more benefits from treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DR30206Also: DR30206 for InjectionSubjects receive DR30206 intravenously | Drug | DR30206, Phase Ib: DR30206 |
Primary outcome
PartA: Incidence of dose limiting toxicities (DLTs)
Time frame: 21 days following first dose
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
PartA: Maximum tolerated dose (MTD)
Time frame: 21 days following first dose
As measured by number of participants experiencing dose related toxicity (DLT) in each escalating cohort
PartA: Recommend dose of expansion(RDE)
Time frame: 21 days following first dose
A Recommend dose of expansion will be determined based on safety data
PartA+B: Adverse evens (AEs)
Time frame: Up to 90 days after last dose
The incidence and severity of AEs graded according to NCI-CTCAE v5.0
PartA+B: Serious adverse evens (SAEs)
Time frame: Up to 90 days after last dose
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
PartB: Objective response rate (ORR)
Time frame: Up to approximately 12 months
Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1
PartB: Recommended phase 2 dose (RP2D)
Time frame: 21 days following first dose
A recommended phase 2 dose will be determined based on safety data
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Caicun Zhou, MD principal investigator
Shanghai Pulmonary Hospital, Shanghai, China
Yanshan Huang, PhD study chair
Zhejiang Doer Biologics Co., Ltd.
Junfang Xu, MD study director
Huadong Medicine Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DR30206 in people with Solid Tumor, 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 10 inclusion and 23 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 27 Apr 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 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.
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 Senior Clinical Operations Director (+86 151 94 40 28 68, yg@doerbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PartA: Incidence of dose limiting toxicities (DLTs) (time frame: 21 days following first dose). The study lists 7 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 27 Apr 2026.