EGFR Mutant NSCLC and Platinum Resistant Ovarian CancerPhase 2NCT07124793

A Study of IBI363 Combination Therapy in Participants With Advanced Solid Tumors

A Phase 2 study testing IBI363+IBI305 in people with EGFR Mutant NSCLC and Platinum Resistant Ovarian Cancer, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: EGFR Mutant NSCLC and Platinum Resistant Ovarian Cancer
What is being tested?: IBI363+IBI305
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteChina
Study dates: 31 Aug 2025to 30 Sep 2028
Phase: Phase 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

Subjects must meet all of the following inclusion criteria to be enrolled in the study:
Sign the written informed consent form and be able to comply with the visit arrangements and related procedures specified in the protocol.
Aged >= 18 years and <= 75 years, regardless of gender.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
Expected survival time >= 3 months.
Locally advanced or metastatic solid tumors confirmed by histology or cytology that are inoperable and cannot receive radical concurrent radiotherapy and chemotherapy:

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Cohort A (EGFR-mutated NSCLC):
Histologically or cytologically confirmed unresectable locally advanced or metastatic non-small cell lung cancer;
Documented EGFR mutation (ex19del or L858R) detected in tumor tissue or blood samples;
Have progressed on or are intolerant to at least 1 prior line of approved EGFR TKI for metastatic or locally advanced NSCLC.T790M mutation requires 3rd generation TKI;
Patients with metastatic or locally advanced NSCLC who have shown progression or intolerance after at least 1 line of platinum-based chemotherapy;
Intolerance to or progression of the most recent line of anti-tumor therapy.
Cohort B (PROC):
Histologically or cytologically confirmed locally advanced unresectable or metastatic ovarian cancer, primary peritoneal cancer, or fallopian tube cancer;
Subjects with a documented breast cancer gene (BRCA) mutation (germline and/or somatic) must have been previously treated with a poly(ADP-ribose) polymerase (PARP) inhibitor;
For subjects with documented positive folate receptor-α (FRα) expression in tumor tissues, they should have previously received mirvetuximab soravtansine (MIRV) or ADC drugs with the same target, and have radiologically or pathologically confirmed PD;
Patients who have previously received ≥ 1 line of platinum-based chemotherapy and experienced progressive disease;
If you have only received 1 line of platinum-based chemotherapy, you must have received at least 4 cycles of platinum-based therapy, the best response is PR or CR, and disease progression occurs > 3 months and < 6 months after the last platinum-based chemotherapy;
If receiving 2 or more lines of platinum-based chemotherapy, must have had disease progression during or < 6 months after the last line of platinum-based chemotherapy Note: Disease progression is confirmed by imaging or pathology.
Must have received at least 1 line of prior systemic anti-cancer therapy:
Adjuvant ± neoadjuvant therapy is considered as first-line systemic anti-tumor treatment;
Maintenance therapy [e.g., bevacizumab and PARP inhibitors] as part of front-line anti-tumor treatment (the number of lines will not be counted separately);
For a change in treatment regimen, if the changed therapeutic drug is the same type of drug as the previous first-line treatment (for example, platinum, taxane, anthracycline, PARP inhibitor, etc. before and after the change), and there is no imaging disease progression before the change in therapeutic drug, the changed therapeutic regimen will be considered as part of the number of lines of treatment as before and will not be counted separately;
If the changed therapeutic drug is a different type of drug from the previous first-line treatment, or if radiographic disease progression occurs before the change of treatment, the number of lines needs to be calculated separately.
Adequate bone marrow and organ function:
Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; eosinophils < 1.5 × upper limit of normal (ULN); platelet count (PLT) ≥ 100 × 109/L; hemoglobin ≥ 9.0 g/dL; have not received treatment with erythropoietin (EPO), granulocyte-colony stimulating factor (G-CSF), or granulocyte-macrophage colony stimulating factor (GM-CSF) within 14 days prior to the first dose, and have not received blood transfusion (including red blood cell and platelet transfusion) within at least 14 days;
Liver function: total bilirubin ≤ 1.5 × ULN; AST and ALT ≤ 2.5 × ULN, without liver metastasis (if liver metastasis is present, ≤ 5 × ULN); albumin ≥ 3.0 g/dL (without albumin infusion within 14 days before the first dose);
Renal function: serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 60 mL/min (using Cockcroft-Gault formula [Appendix 4]); and urine protein < 2+ or total 24-h urine protein < 1 g;
Coagulation function: International normalized ratio (INR) ≤ 1.5; activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (subjects receiving anticoagulant therapy with coagulation function within the above range are allowed to be enrolled);
At least one measurable lesion according to RECIST v1.1.
For female subjects of childbearing age, a negative urine or serum pregnancy test within 7 days prior to receiving the first study drug administration. If the urine pregnancy test result is positive, a blood pregnancy test is required to be clearly negative or not pregnant;

Who cannot join

Cohort B (PROC) should not be enrolled if any of the following criteria is met based on histological or cytological findings:
Documented sarcoma, mucinous carcinoma, undifferentiated carcinoma, or a combination thereof;
Confirmed low-grade or borderline tumors, or contains the above components.
Previously received IL-2/IL-15 cytokine therapy. Except for the use of IL-2/IL-15 as an adjuvant component of adoptive cell therapy or as an immunomodulatory therapy for immunocompromised subjects.
Excluded medications and other treatments (subjects should not receive any of the following treatments):
Have received small-molecule targeted therapy or oral chemotherapy within 2 weeks or 5 half-lives (whichever is longer) before the first dose of the study drug; have received intravenous infusion of chemotherapy drugs within 3 weeks before the first dose of the study drug; have received Chinese herbal medicines with anti-tumor indications within 2 weeks before the first dose of the study drug;

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Nitrosourea antineoplastic agents and mitomycin C within 6 weeks prior to the first dose of study drug;
Use of any antibody-based anti-tumor therapy within 4 weeks prior to the first dose of the study drug;
Participation in any medical device or other therapeutic interventional clinical trial within 2 weeks prior to the first dose of study drug;
Palliative radiotherapy within 2 weeks prior to the first dose of the investigational product, or radical radiotherapy within 4 weeks prior to the first dose;
Received adoptive cell therapy within 8 weeks prior to the first dose of study drug;
Use of live vaccines against infectious disease prophylaxis within 4 weeks prior to the first dose of study drug.
Active or untreated central nervous system metastasis (such as brain or leptomeningeal metastasis) confirmed by imaging assessment during screening or previous imaging assessment.
Subjects with asymptomatic brain metastases (i.e., no neurologically relevant symptoms, no corticosteroid treatment is required, and the diameter of metastatic lesions is ≤ 1.5 cm) may participate in this study.
Subjects whose symptoms of brain metastases are stable for ≥ 4 weeks after treatment and whose brain metastases do not increase in number or further increase after the end of treatment may participate in this study as long as they meet all of the following criteria:
Measurable lesions outside the central nervous system;
No metastases to meninges, midbrain, pons, medulla oblongata, or spinal cord; no multiple cerebellar metastases;
No compression of the aqueduct of the midbrain, no compression of the third or fourth ventricle, and no spinal cord compression;
Hormone therapy is discontinued 14 days prior to the first dose of the study drug.
Note: Central nervous system lesions are not considered target lesions.
The tumor invades surrounding important tissue structures (such as mediastinal great vessels, superior vena cava, inferior vena cava, pericardium, heart, trachea, esophagus, etc.) or has the risk of gastrointestinal/respiratory fistula.
The subject has a history of significant toxicity related to immune checkpoint inhibitor administration and requires permanent discontinuation of the treatment.
Subjects with adverse reactions related to any previous anti-tumor treatment that have not recovered to Grade 0-1; except for persistent Grade 2 alopecia, peripheral neuropathy, hypomagnesemia, toxicities that are expected to be unrecoverable but stably controlled by the drug, and other conditions that the investigator considers to have no safety risk.
Have not recovered sufficiently from previous surgery, or have undergone any major surgery within 4 weeks prior to the first dose of the study drug.
Cardiovascular and cerebrovascular diseases with significant clinical significance, including:
Ventricular arrhythmia or other uncontrolled arrhythmias requiring medical intervention, such as antiarrhythmic drug therapy, etc.;
Severe conduction disorders (e.g., 3rd degree atrioventricular block);
HR-corrected QT interval (QTc interval, calculated using the Fridericia method [Appendix 5]) ≥ 480 ms;
Uncontrolled hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg) despite of standard treatment;
History of myocarditis;
Congestive heart failure currently requiring treatment;
Left ventricular ejection fraction (LVEF) < 50%;
Class III or IV cardiovascular disease according to New York Heart Association (NYHA) functional classification;
History of acute coronary syndrome (including myocardial infarction and unstable angina), coronary angioplasty or stenting within 6 months prior to the first dose of the study drug;
History of any arterial thromboembolic events within 6 months prior to the first dose of study treatment, including myocardial infarction, unstable angina, cerebrovascular accident, etc.
History of deep vein thrombosis, pulmonary embolism, or any other serious thromboembolic event within 3 months prior to the first dose of study drug (thrombus or catheter-derived thrombus caused by an implanted venous port or superficial venous thrombosis is not considered a serious thromboembolism).
Known active seizures.
Subjects with interstitial pneumonia requiring steroid hormones or other treatments, or a history of other clinically significant lung diseases (such as pulmonary fibrosis, pneumoconiosis, interstitial lung disease, non-infectious pneumonia), or uncontrolled lung diseases (such as pulmonary fibrosis, severe radiation pneumonitis and acute lung injury) or suspected of having such diseases through imaging examinations during the screening period.
Allergic constitution, asthma, history of atopic dermatitis.
Pleural effusion, abdominal effusion or pericardial effusion requiring drainage or with obvious symptoms.
Active autoimmune diseases requiring systemic treatment (such as the use of disease-modifying drugs, corticosteroids or immunosuppressants) occurred within 2 years before the first administration. Alternative therapies (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatments.
Have used immunosuppressive drugs within 14 days before the first study treatment, excluding intranasal and inhaled corticosteroids, or use systemic corticosteroids with a dose of less than 10 mg/day prednisone (or other corticosteroids with an equivalent dose to 10 mg/day prednisone), or use corticosteroids to prevent allergy to contrast agents.
Known allogeneic organ transplantation;

Trial locations and contacts

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

Xiaodong Sun contact

0512-69566088-8095

xiaodong.sun@innoventbio.com

China1 site

Tongji Hospital affiliated to Tongji Medical College HUST
Wuhan, Hubei, 430030
Qinglei Gao, 027-83662640, aoqlgcp@163.com

Other trials in China

About this study

Official title: Phase II Study to Evaluate the Efficacy and Safety of IBI363 in Combination With IBI305 in Participants With Advanced Solid Tumors

CIBI363A203, a Phase 2 study to evaluate the safety, tolerability and preliminary efficacy of IBI363 combined with IBI305 (a bevacizumab biosimilar) in participants with advanced malignancies conducted in China. Primary endpoint is objective response rate (ORR) per RECIST v1.1. Secondary endpoints include DoR, DCR, TTR, PFS, per RECIST v1.1, and OS; the incidence and severity of AEs, irAEs, SAEs, AESIs and their relationship to the investigational drug, and changes in vital signs, physical examination, and laboratory values before and after study treatment; PK, and immunogenicity of IBI363. The cohorts include: IBI363 and IBI305 combination therapy in participants with advanced EGFRmut NSCLC progressed after EGFR TKI and Platinum-based chemotherapy, and advanced platinum-resistant ovarian cancer (PROC). The anticipated enrollment for this study is approximately 60 participants with each cohort 30 participants, and actual enrollment may change with future amendments as cohorts are opened and closed based on evolving data.

Conditions: EGFR Mutant NSCLC and Platinum Resistant Ovarian Cancer
Being tested: IBI363+IBI305

What participants receive

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

IBI363+IBI305Drug
Each treatment cycle lasts for 21 days (the first treatment cycle is 28 days). Subjects will receive IBI363 Q3W in combination with bevacizumab Q3W until 2 years of treatment, PD, intolerable toxicity, start of new anti-tumor treatment, withdrawal of informed consent, death, or study termination (whichever occurs first).

Study groups in NCT07124793
Study group	Role	What they receive
platinum resistant ovarian cancer	Experimental	Not described Receives: Drug: IBI363+IBI305
EGFR mutant NSCLC cohort	Experimental	Not described Receives: Drug: IBI363+IBI305

What is being measured

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

Objective response rate (ORR)
Measured: Through out the study (up to 2 years)

Secondary outcomes (16)

disease control rate (DCR)
To evaluate the preliminary antitumor activity of IBI363 plus bevacizumab.
Measured: Through out the study (up to 2 years)
duration of response (DoR)
To evaluate the preliminary antitumor activity of IBI363 plus bevacizumab.
Measured: Through out the study (up to 2 years)
time to response (TTR)
To evaluate the preliminary antitumor activity of IBI363 plus bevacizumab.
Measured: Through out the study (up to 2 years)
progression-free survival (PFS)
To evaluate the preliminary antitumor activity of IBI363 plus bevacizumab.
Measured: Through out the study (up to 2 years)
Overall survival (OS)
To evaluate the preliminary antitumor activity of IBI363 plus bevacizumab.
Measured: Through out the study (an average of 2 years)
Adverse Enent (AE)
AE is defined as an unexpected medical problem that happens during treatment with a drug or other therapy.
Measured: Up to 90 days after the last administration
Treatment-Emergent AE (TEAE)
A TEAE will be defined as any new AE that begins, or any pre-existing condition that worsens in severity, after at least 1 dose of study treatment has been administered.
Measured: Up to 90 days after the last administration
Immune-related AE (irAE)
irAE is defined as all grades of adverse drug reactions in clinical trials of anti-tumor drugs/therapies that are determined to be causally related to immune mechanisms.
Measured: Up to 90 days after the last administration
Adverse Event of Special Interest (AESI)
AESI (Adverse Event of Special Interest) refers to adverse events that require special close monitoring to enhance the understanding of the investigational drug's safety. AESIs may be non-serious events.
Measured: Up to 90 days after the last administration
Serious Adverse Event (SAE)
An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is an important medical event that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before.
Measured: Through out the study (up to 2 years)
Plasma concentration (Cmax) of IBI363
PK parameters to be evaluated for IBI363 including maximum concentration (Cmax) will be determined when appropriate.
Measured: Up to 2 years
Area under the curve (AUC) of IBI363
PK parameters to be evaluated for IBI363 including area under the curve (AUC) will be determined when appropriate.
Measured: Up to 2 years
Half-life (T1/2) of IBI363
PK parameters to be evaluated for IBI363 including half-life (t1/2) will be determined when appropriate.
Measured: Up to 2 years
Clearance (CL) of IBI363
PK parameters to be evaluated for IBI363 including clearance (CL) will be determined when appropriate.
Measured: Up to 2 years
Volume of distribution (V) of IBI363
PK parameters to be evaluated for IBI363 including volume of distribution (V) will be determined when appropriate.
Measured: Up to 2 years
Immunogenicity of IBI363
Each subject will be tested for anti-drug (IBI363) antibody (ADA), and ADA-positive serum samples will continue to be tested for neutralizing antibodies (NAb).
Measured: Up to 2 years

Timeline

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

31 Aug 202530 Sep 2028

First posted15 Aug 2025
Study start31 Aug 2025 (estimated)
Primary completion30 Sep 2026 (estimated)
Study completion30 Sep 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for EGFR Mutant NSCLC and Platinum Resistant Ovarian CancerStudies of the same condition, open and under way.
More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
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 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07124793
Sponsor's protocol ID: CIBI363A203
Status last verified: Aug 2025
First submitted: 7 Aug 2025
Last updated: 15 Aug 2025
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 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Study to Evaluate the Efficacy and Safety of IBI363 in Combination With IBI305 in Participants With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT07124793
Acronym / sponsor ID: CIBI363A203
Conditions: EGFR Mutant NSCLC and Platinum Resistant Ovarian Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 60 participants (estimated)
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
Study start: 31 Aug 2025 (estimated)
Primary completion: 30 Sep 2026 (estimated)
Study completion: 30 Sep 2028 (estimated)
First posted: 15 Aug 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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
platinum resistant ovarian cancer	Experimental	Drug: IBI363+IBI305
EGFR mutant NSCLC cohort	Experimental	Drug: IBI363+IBI305

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (31 listed)

Sign the written informed consent form and be able to comply with the visit arrangements and related procedures specified in the protocol.
Aged >= 18 years and <= 75 years, regardless of gender.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
Expected survival time >= 3 months.
Locally advanced or metastatic solid tumors confirmed by histology or cytology that are inoperable and cannot receive radical concurrent radiotherapy and chemotherapy:

Key exclusion criteria (43 listed)

Cohort B (PROC) should not be enrolled if any of the following criteria is met based on histological or cytological findings:
Previously received IL-2/IL-15 cytokine therapy. Except for the use of IL-2/IL-15 as an adjuvant component of adoptive cell therapy or as an immunomodulatory therapy for immunocompromised subjects.
Excluded medications and other treatments (subjects should not receive any of the following treatments):
Active or untreated central nervous system metastasis (such as brain or leptomeningeal metastasis) confirmed by imaging assessment during screening or previous imaging assessment.
Note: Central nervous system lesions are not considered target lesions.

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
IBI363+IBI305Each treatment cycle lasts for 21 days (the first treatment cycle is 28 days). Subjects will receive IBI363 Q3W in combination with bevacizumab Q3W until 2 years of treatment, PD, intolerable toxicity, start of new anti-tumor treatment, withdrawal of informed consent, death, or study termination (whichever occurs first).	Drug	EGFR mutant NSCLC cohort, platinum resistant ovarian cancer

Primary outcome

Objective response rate (ORR)
Time frame: Through out the study (up to 2 years)

16 secondary outcomes

disease control rate (DCR)
Time frame: Through out the study (up to 2 years)
duration of response (DoR)
Time frame: Through out the study (up to 2 years)
time to response (TTR)
Time frame: Through out the study (up to 2 years)
progression-free survival (PFS)
Time frame: Through out the study (up to 2 years)
Overall survival (OS)
Time frame: Through out the study (an average of 2 years)
Adverse Enent (AE)
Time frame: Up to 90 days after the last administration
Treatment-Emergent AE (TEAE)
Time frame: Up to 90 days after the last administration
Immune-related AE (irAE)
Time frame: Up to 90 days after the last administration
Adverse Event of Special Interest (AESI)
Time frame: Up to 90 days after the last administration
Serious Adverse Event (SAE)
Time frame: Through out the study (up to 2 years)
Plasma concentration (Cmax) of IBI363
Time frame: Up to 2 years
Area under the curve (AUC) of IBI363
Time frame: Up to 2 years
Half-life (T1/2) of IBI363
Time frame: Up to 2 years
Clearance (CL) of IBI363
Time frame: Up to 2 years
Volume of distribution (V) of IBI363
Time frame: Up to 2 years
Immunogenicity of IBI363
Time frame: Up to 2 years

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 15 Aug 2025.

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.

Xiaodong Sun contact

0512-69566088-8095

xiaodong.sun@innoventbio.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IBI363+IBI305 in people with EGFR Mutant NSCLC and Platinum Resistant Ovarian Cancer, run by Innovent Biologics (Suzhou) 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 31 inclusion and 43 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: opening soon, as of the sponsor's last update on 15 Aug 2025. 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 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 Xiaodong Sun (0512-69566088-8095, xiaodong.sun@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: Through out the study (up to 2 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07124793.

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 15 Aug 2025.