Solid MalignanciesPhase 1NCT06933069
Safety and Tolerability of CMAB017 In Patients With Advanced Solid Tumors
A Phase 1 study testing CMAB017 in people with Solid Malignancies, run by Taizhou Mabtech Pharmaceutical Co.,Ltd at 1 site in China.
Trial summary
This is a multicenter, open-lable phase Ia clinical study to evaluate the safety, tolerability, pharmacokinetic profile and preliminary antitumor activity of CMAB017 in advanced malignant solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Malignancies
- What is being tested?
- CMAB017
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 9 Jun 2025to 30 Jun 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
- fully understand and agree to sign the Informed Consent Form (ICF);
- histologically or cytologically confirmed, inoperable, locally advanced, recurrent or metastatic malignant solid tumors, including but not limited to head and neck squamous carcinoma, RAS wild-type colorectal cancer, esophageal squamous carcinoma, etc., for which the patient has failed standard treatment, does not have standard treatment, or refuses standard treatment;
- age 18~75 years old, gender is not limited;
- Eastern Cooperative Oncology Group (ECOG) score ≤1;
- expected survival ≥ 3 months;
- presence of at least one evaluable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 (bone-only metastases or central nervous system-only metastases will not be accepted as evaluable lesions); starting from 6 mg/kg Q3W, 4 mg/kg Q2W after the start of the dose group, presence of at least one measurable lesion; and dose groups, at least one measurable lesion is present (bone-only metastases or CNS-only metastases will not be accepted as measurable lesions);
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- females of childbearing potential must be non-lactating and have a negative serum pregnancy test within 1 week prior to the first infusion and agree to use effective contraception from the time of signing the ICF until 6 months after the last infusion; male subjects must agree to use effective contraception from the time of signing the ICF until 6 months after the last infusion;
- Blood routine and liver and kidney functions during the screening period meet the following conditions:
- Blood routine: neutrophils ≥1.5×109/L; platelets ≥75×109/L; hemoglobin ≥90 g/L;
- Liver function: alanine aminotransferase and aspartate aminotransferase ≤3×ULN (both should be ≤5×ULN for those with tumor liver metastasis); total bilirubin ≤1.5×ULN; ③ Coagulation function: activated partial thromboplastin time (APTT) ≤1.5×ULN; international normalized ratio (INR) ≤1.5×ULN (for patients not receiving anticoagulation therapy; APTT or INR of subjects receiving anticoagulation therapy should be within the expected therapeutic range of anticoagulant drugs); ④ Renal function: blood creatinine ≤ 1.5 x ULN; if creatinine > 1.5 x ULN, creatinine clearance (Ccr) > 50mL/min is required (calculated according to the Cockcroft-Gault formula).
Who cannot join
- With known active CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may be enrolled in the study provided that they have been clinically stable for at least 2 weeks, have no evidence of new or expanding brain metastases, and have discontinued steroids within 2 weeks prior to the infusion of the trial drug. Stability of brain metastases should be determined prior to the first dose of the trial drug infusion. Patients with asymptomatic brain metastases (i.e., no neurologic symptoms, no need for medication, and no lesion with a longest diameter >1.5 cm) may be enrolled, but will be required to undergo periodic imaging;
- subjects with grade ≥2 corneal abnormalities present at screening;
- adverse effects of prior antineoplastic therapy that have not recovered to a CTCAE 5.0 grade rating of ≤ grade 1 or to the level specified in the entry criteria (except for toxicities judged by the investigator to be of no safety risk, e.g., alopecia, grade 2 peripheral neurotoxicity, and hypothyroidism stabilized by hormone replacement therapy)
- other malignancies within the previous 5 years, usually with the exception of the following: a. any other aggressive malignancy (for which the subject has had adequate treatment) for which disease-free status has persisted for >3 years and which, in the investigator's assessment, would not interfere with the assessment of oncologic efficacy; and b. cured basal cell or squamous cell skin cancers, superficial bladder cancers, and locally curable cancers such as prostate, cervical, or breast cancer in situ;
- a history of immunodeficiency, including a positive HIV antibody test, or other acquired or congenital immunodeficiency disease, or a history of organ transplantation
- interstitial lung disease that is symptomatic or may interfere with pulmonary toxicity monitoring associated with the test drug;
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- a history of serious cardiovascular or cerebrovascular disease, including, but not limited to: severe cardiac rhythm or conduction block, such as ventricular arrhythmia requiring clinical intervention, degree III atrioventricular block, etc.; QTc intervals > 480 ms on 12/15 lead ECG at rest; acute coronary syndrome, congestive heart failure, aortic dissection, stroke within 6 months prior to the first infusion or other grade 3 or higher cardiovascular events; NYHA cardiac function classification ≥ grade II or LVEF <50%; clinically uncontrollable hypertension;
- any of the following within 4 weeks prior to the first trial drug infusion:
- Has had major surgery (defined as surgery requiring general anesthesia).
- has participated in a clinical trial and received investigational treatment or used an investigational device.
- Undergoing or planning other antineoplastic therapy outside of this study protocol (certain specific antineoplastic agents may be excluded from the 4 weeks prior to drug infusion, e.g., oral fluorouracil ≥ 2 weeks; mitomycin C, nitrosoureas ≥ 6 weeks; and small molecule targeted therapy ≥ 2 weeks);
- any of the following within 2 weeks prior to the first trial drug infusion:
- Having had localized palliative radiotherapy.
- Received herbal/proprietary Chinese medicines that are clearly indicated for the treatment of oncological indications.
- Has had minor surgery (other than major surgery, but diagnostic procedures such as incision and/or needle core biopsy are not considered minor surgery).
- Received blood transfusion, erythropoietin, granulocyte colony-stimulating factor or granulocyte-macrophage colony-stimulating factor therapy;
- known intolerance to anti-EGFR monoclonal antibodies resulting in discontinuation due to rash, gastrointestinal toxicity, or other Grade 3 or 4 toxicity;
- Hepatitis B or C virologic testing at screening meets any of the following:
- HBsAg positive and peripheral blood hepatitis B virus deoxyribonucleic acid (HBV-DNA) titer test ≥1000 copies/mL or ≥200 IU/mL;
- Positive antibody to HCV;
- known severe allergic reaction to any component of the test drug or multiple drugs;
- third interstitial fluid that, in the opinion of the investigator, is clinically uncontrollable;
- any other serious or uncontrollable medical condition, active infection currently requiring intravenous anti-infective therapy, abnormal physical examination, abnormal laboratory tests, abnormal mental status, or psychiatric illness that, in the opinion of the Investigator, results in increased risk to the subject or otherwise affects the evaluation of study results.
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 East Hospital
Shanghai, 200123
Ye Guo, Ph.D, 021-38804518-22132, pattrick.guo@gmail.com
About this study
Official title: A Multicenter, Open-label Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Preliminary Anti-tumor Activity of CMAB017 in Advanced Malignant Solid Tumors
This is a multicenter, open-lable phase Ia clinical study to evaluate the safety, tolerability, pharmacokinetic profile and preliminary antitumor activity of CMAB017 in advanced malignant solid tumors.
Read the detailed description
This is a multicenter, open-lable, phase Ia study of CMAB017 which is planned to enroll about 55 patients with advanced solid tumors. The study is divided into the core period and the extension period.The core period involves the first four administrations of the drug, divided into two cohorts: the Q3W cohort (administering once every three weeks) and the Q2W cohort (administering once every two weeks). The pharmacokinetic profile and immunogenicity after completing dose escalation and observation for a total of four administrations are to be evaluated. In the extension period, for those subjects with therapeutic effects and tolerable side effects, the drug administration is to be prolonged. Further observations are to be made on the long-term safety, pharmacokinetic characteristics, immunogenicity, and anti-tumor effects of the treatment.
- Conditions
- Solid Malignancies
- Being tested
- CMAB017
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMAB017Drug
CMAB017 was administered at a preset dose, and body weight was measured before each study dose; if body weight changed ≥10% from baseline, the dose should be recalculated. Administration was by intravenous infusion: for doses ≤1000 mg, intravenous infusion lasted 60±5 min; for doses >1000 mg, intravenous infusion lasted 90±5 min.
| Study group | Role | What they receive |
|---|---|---|
| CMAB017 | Experimental | CMAB017 100 mg intravenous (IV) solution for Injection every 3 weeks (Q3W) or every 2 weeks (Q2W) Receives: Drug: CMAB017 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities，DLT
Measured: Up to 12 weeks
Maximal Tolerated Dose，MTD
Measured: Up to 12 weeks
Secondary outcomes (9)
Safety: The severity and incidence of other adverse events (AE) outside DLT
Measured: Date of the first dosing of study drug to 28 days post last dose of study drug.
Peak blood Concentration (Cmax)
Measured: Day 1 to Day 15
Trough blood Concentration (Cmin)
Measured: Day 1 to Day 15
Steady-state area under the plasma concentration versus time curve (AUC0-τ)
Measured: Day 1 to Day 15
Half life (t1/2)
Measured: Day 1 to Day 15
Time to reach maximum concentration (Tmax)
Measured: Day 1 to Day 15
Clearance (CL）
Measured: Day 1 to Day 15
Steady-state apparent volume of distribution (Vss)
Measured: Day 1 to Day 15
Immunogenicity: The occurrence rate of ADA and neutralizing antibody (Nab)
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start9 Jun 2025
- Primary completion31 May 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid MalignanciesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taizhou Mabtech Pharmaceutical Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933069
- Sponsor's protocol ID
- CMAB017-001
- Status last verified
- Oct 2026
- First submitted
- 1 Apr 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Preliminary Anti-tumor Activity of CMAB017 in Advanced Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT06933069
- Acronym / sponsor ID
- CMAB017-001
- Conditions
- Solid Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Taizhou Mabtech Pharmaceutical Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 18 Apr 2025 (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 is a multicenter, open-lable phase Ia clinical study to evaluate the safety, tolerability, pharmacokinetic profile and preliminary antitumor activity of CMAB017 in advanced malignant solid tumors.
Detailed description
This is a multicenter, open-lable, phase Ia study of CMAB017 which is planned to enroll about 55 patients with advanced solid tumors. The study is divided into the core period and the extension period.The core period involves the first four administrations of the drug, divided into two cohorts: the Q3W cohort (administering once every three weeks) and the Q2W cohort (administering once every two weeks). The pharmacokinetic profile and immunogenicity after completing dose escalation and observation for a total of four administrations are to be evaluated. In the extension period, for those subjects with therapeutic effects and tolerable side effects, the drug administration is to be prolonged. Further observations are to be made on the long-term safety, pharmacokinetic characteristics, immunogenicity, and anti-tumor effects of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CMAB017 | Experimental | Drug: CMAB017CMAB017 100 mg intravenous (IV) solution for Injection every 3 weeks (Q3W) or every 2 weeks (Q2W) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- fully understand and agree to sign the Informed Consent Form (ICF);
- histologically or cytologically confirmed, inoperable, locally advanced, recurrent or metastatic malignant solid tumors, including but not limited to head and neck squamous carcinoma, RAS wild-type colorectal cancer, esophageal squamous carcinoma, etc., for which the patient has failed standard treatment, does not have standard treatment, or refuses standard treatment;
- age 18~75 years old, gender is not limited;
- Eastern Cooperative Oncology Group (ECOG) score ≤1;
- expected survival ≥ 3 months;
Key exclusion criteria (23 listed)
- With known active CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may be enrolled in the study provided that they have been clinically stable for at least 2 weeks, have no evidence of new or expanding brain metastases, and have discontinued steroids within 2 weeks prior to the infusion of the trial drug. Stability of brain metastases should be determined prior to the first dose of the trial drug infusion. Patients with asymptomatic brain metastases (i.e., no neurologic symptoms, no need for medication, and no lesion with a longest diameter >1.5 cm) may be enrolled, but will be required to undergo periodic imaging;
- subjects with grade ≥2 corneal abnormalities present at screening;
- adverse effects of prior antineoplastic therapy that have not recovered to a CTCAE 5.0 grade rating of ≤ grade 1 or to the level specified in the entry criteria (except for toxicities judged by the investigator to be of no safety risk, e.g., alopecia, grade 2 peripheral neurotoxicity, and hypothyroidism stabilized by hormone replacement therapy)
- other malignancies within the previous 5 years, usually with the exception of the following: a. any other aggressive malignancy (for which the subject has had adequate treatment) for which disease-free status has persisted for >3 years and which, in the investigator's assessment, would not interfere with the assessment of oncologic efficacy; and b. cured basal cell or squamous cell skin cancers, superficial bladder cancers, and locally curable cancers such as prostate, cervical, or breast cancer in situ;
- a history of immunodeficiency, including a positive HIV antibody test, or other acquired or congenital immunodeficiency disease, or a history of organ transplantation
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 |
|---|---|---|
| CMAB017CMAB017 was administered at a preset dose, and body weight was measured before each study dose; if body weight changed ≥10% from baseline, the dose should be recalculated. Administration was by intravenous infusion: for doses ≤1000 mg, intravenous infusion lasted 60±5 min; for doses >1000 mg, intravenous infusion lasted 90±5 min. | Drug | CMAB017 |
Primary outcome
Dose Limiting Toxicities，DLT
Time frame: Up to 12 weeks
Maximal Tolerated Dose，MTD
Time frame: Up to 12 weeks
9 secondary outcomes
Safety: The severity and incidence of other adverse events (AE) outside DLT
Time frame: Date of the first dosing of study drug to 28 days post last dose of study drug.
Peak blood Concentration (Cmax)
Time frame: Day 1 to Day 15
Trough blood Concentration (Cmin)
Time frame: Day 1 to Day 15
Steady-state area under the plasma concentration versus time curve (AUC0-τ)
Time frame: Day 1 to Day 15
Half life (t1/2)
Time frame: Day 1 to Day 15
Time to reach maximum concentration (Tmax)
Time frame: Day 1 to Day 15
Clearance (CL）
Time frame: Day 1 to Day 15
Steady-state apparent volume of distribution (Vss)
Time frame: Day 1 to Day 15
Immunogenicity: The occurrence rate of ADA and neutralizing antibody (Nab)
Time frame: Up to 1 year
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 21 Oct 2026.
- Individual participant dataSharing planned: No
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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.
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 CMAB017 in people with Solid Malignancies, run by Taizhou Mabtech Pharmaceutical 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 21 Oct 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 Ye Guo Principal Investigator (021-38804518-22132, pattrick.guo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicities，DLT (time frame: Up to 12 weeks). The study lists 2 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 21 Oct 2026.