Study of IBI3005 Combination Therapy in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors

NCT07612137 | Not Yet Recruiting Phase 1

• 1 other identifier: CIBI3005A102
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and tolerability of IBI3005 combination therapy in participants with advanced solid tumors; to evaluate the antitumor activity of IBI3005 combination therapy in participants with advanced solid tumors.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (14)

• Number of subjects with adverse events

  defined as any untoward medical occurrence, whether or not thereis a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed

  Up to 3 years

• Number of subjects with treatment emergent adverse events

  defined as any untoward medical occurrence, whether or not thereis a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed

  Up to 3 weeks

• Number of subjects with adverse events of special interest

  defined as any untoward medical occurrence, whether or not thereis a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed

  Up to 3 years

• Number of subjects with serious adverse events

  defined as any untoward medical occurrence, whether or not thereis a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed

  Up to 3 years

• Dose limiting toxicities (DLTs)

  Dose limiting toxicities (DLTs) to establish MTD and/or RP2D.

  Up to 3 weeks

• Number of subjects with clinically significant changes in laboratory tests results

  Clinically significant abnormal laboratory tests results reported by the investigator.

  Up to 3 years

• Number of subjects with clinically significant changes in physical examination results

  Clinically significant abnormal physical examination findings reported by the investigator.

  Up to 3 years

• Number of subjects with clinically significant changes in vital signs

  Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure

  Up to 3 years

• Objective Response Rate, (ORR）

  as evaluated per the RECIST v1.1 criteria.

  Up to 3 years

• duration of response (DCR)

  as evaluated per the RECIST v1.1 criteria.

  Up to 3 years

• time to response (TTR)

  as evaluated per the RECIST v1.1 criteria.

  Up to 3 years

• duration of response (DoR)

  as evaluated per the RECIST v1.1 criteria.

  Up to 3 years

• progression free survival (PFS)

  as evaluated per the RECIST v1.1 criteria.

  Up to 3 years

• overall survival (OS)

  Up to 3 years

Secondary Outcomes (7)

• area under the curve (AUC)

  Up to 3 years

• maximum concentration (Cmax)

  Up to 3 years

• time to maximum concentration (Tmax)

  Up to 3 years

• clearance (CL)

  Up to 3 years

• apparent volume of distribution (V)

  Up to 3 years

Study Arms (3)

Cohort 1：IBI3005+Sintilimab+ Carboplatin+IBI305

EXPERIMENTAL

Drug: IBI3005; Drug: Sintilimab; Drug: Bevacizumab biosimilar; Drug: Carboplatin

Cohort 2：IBI3005+Sintilimab+ Carboplatin

EXPERIMENTAL

Drug: IBI3005; Drug: Sintilimab; Drug: Carboplatin

Cohort 3：IBI3005+Limertinib/Osimertinib

EXPERIMENTAL

Drug: IBI3005; Drug: Limertinib; Drug: Osimertinib

Interventions

IBI3005 DRUG

Bispecific Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R \& D code: IBI3005)

Cohort 1：IBI3005+Sintilimab+ Carboplatin+IBI305; Cohort 2：IBI3005+Sintilimab+ Carboplatin; Cohort 3：IBI3005+Limertinib/Osimertinib

Sintilimab DRUG

Anti-PD-1 Monoclonal Antibody

Cohort 1：IBI3005+Sintilimab+ Carboplatin+IBI305; Cohort 2：IBI3005+Sintilimab+ Carboplatin

Bevacizumab biosimilar DRUG

Recombinant humanized anti-VEGF monoclonal antibody

Cohort 1：IBI3005+Sintilimab+ Carboplatin+IBI305

Limertinib DRUG

Third-generation EGFR-TKI

Cohort 3：IBI3005+Limertinib/Osimertinib

Osimertinib DRUG

Third-generation EGFR-TKI

Cohort 3：IBI3005+Limertinib/Osimertinib

Carboplatin DRUG

Second-generation platinum-based chemotherapy drugs

Cohort 1：IBI3005+Sintilimab+ Carboplatin+IBI305; Cohort 2：IBI3005+Sintilimab+ Carboplatin

Eligibility Criteria

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

You may qualify if:

• Has signed a written informed consent form (ICF) and is able to comply with the scheduled study visits and related procedures.
• Age ≥ 18 years, irrespective of gender.
• Confirmed diagnosis of locally advanced unresectable or metastatic solid tumor.
• Expected survival ≥ 12 weeks.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1.
• Left ventricular ejection fraction (LVEF) ≥ 50% within 28 days prior to the first study drug administration.
• Adequate bone marrow and organ function.
• Histologically or cytologically confirmed unresectable locally advanced or metastatic NSCLC.
• Tumor harboring EGFR-sensitive mutations (Ex19del or L858R, with or without other EGFR mutations) confirmed via histology or cytology specimens.
• In the safety run-in phase, NSCLC participants who have received prior standard therapy.
• In the cohort expansion phase, participants without driver gene mutations who have not received prior systemic anti-tumor therapy for unresectable locally advanced or metastatic disease.
• Histologically or cytologically confirmed unresectable locally advanced or metastatic non-squamous NSCLC.
• In the safety run-in phase, participants should have received prior standard therapy.
• In the cohort expansion phase:
• Cohort 2A: NSCLC participants without driver gene mutations (including at least EGFR, ALK, and ROS1, with written documentation) who have not received prior systemic anti-tumor therapy for unresectable locally advanced or metastatic disease. Participants who received neoadjuvant/adjuvant therapy are eligible if disease recurrence or progression occurred \>6 months after the last neoadjuvant/adjuvant therapy.

You may not qualify if:

• Participation in any other interventional clinical study, except for observational (non-interventional) studies or the follow-up period after the end of study treatment in an interventional study.
• Prior treatment with antibody-drug conjugate (ADC) drugs bearing a camptothecin or its derivative (topoisomerase I inhibitor) small-molecule payload.
• Prior to the first dose of study drug: a) Within 4 weeks: Received intravenous chemotherapy, macromolecular targeted therapy, antibody-drug conjugates, immunotherapy, endocrine therapy, cell therapy, intraperitoneal perfusion chemotherapy, tumor embolization, or interventional chemotherapy. b) Within 2 weeks or 5 half-lives (whichever is shorter): Received oral chemotherapy, small-molecule targeted therapy, or traditional Chinese herbal medicines indicated for anti-tumor treatment. c) Within 4 weeks: Received radical radiotherapy; within 2 weeks: Received palliative radiotherapy. d) Within 2 weeks or 5 half-lives (whichever is shorter): Received strong inhibitors or strong inducers of cytochrome P450 3A4 (CYP3A4). e) Within 4 weeks: Underwent major surgery (craniotomy, thoracotomy, laparotomy, or other surgeries deemed ""major"" by the investigator, excluding puncture biopsy), or has severe unhealed wounds, trauma, or ulcers; within 2 weeks: Underwent laparoscopic exploratory surgery. f) Within 4 weeks: Received live vaccine (mRNA and non-replicating adenovirus vaccines are not considered live vaccines).
• Presence of adverse events from prior anti-tumor therapy that have not resolved to Grade 0 or 1 per NCI-CTCAE v5.0 \[excluding Grade 2 alopecia, fatigue, pigmentation, insomnia, peripheral neuropathy, hypomagnesemia, and toxicities stably controlled by medication (e.g., hypothyroidism stably controlled by replacement therapy, hypertension with blood pressure stably controlled below 160/100 mmHg by antihypertensive medication)\].
• History of active autoimmune disease requiring systemic therapy (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic therapy.
• History of significant toxicity associated with immune checkpoint inhibitor administration that required permanent discontinuation of such therapy.
• History of active autoimmune disease requiring systemic therapy (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic therapy.
• History of significant toxicity associated with immune checkpoint inhibitor administration that required permanent discontinuation of such therapy.
• History of hemoptysis within 3 months prior to the first dose (blood volume \>2.5 mL per cough or cumulative daily hemoptysis \>10 mL), or current active bleeding.
• Continuous use of aspirin (\>325 mg/day) or other non-steroidal anti-inflammatory drugs known to inhibit platelet function within 2 weeks prior to the first dose."

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

SunYat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Interventions

sintilimab; osimertinib; Carboplatin

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Central Study Contacts

Yang Luo

CONTACT

+86 21 3183 7200; yang.luo@innoventbio.com

Yulong Zhang

CONTACT

+86 21 3183 7200; yulong.zhang@innoventbio.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: May 21, 2026
• First Posted: May 28, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 28, 2026

Record last verified: 2026-05

Locations

CN (1)