Evaluating IBI363 for patients with advanced cancers

Phase Ib Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of IBI363 Combination Therapy in Subjects With Advanced Malignancies

This study is testing a new treatment called IBI363 combined with chemotherapy to see if it helps people with advanced cancers who haven't responded to standard treatments.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 556 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (industry)
• Drugs / interventions: radiation
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06468098 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter Phase Ib study aims to assess the safety, tolerability, and efficacy of IBI363 in patients with advanced malignancies. Participants will receive IBI363 in combination with chemotherapy or the investigator's choice of standard of care. The study will include patients who have either progressed on standard therapies or are unsuitable for them. The primary focus is to determine how well IBI363 works in this challenging patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with histologically or cytologically confirmed advanced malignancies who have progressed on or are unsuitable for standard therapies.

Not a fit: Patients who are pregnant or lactating will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced malignancies who have limited alternatives.

How similar studies have performed: While this approach is being explored in this specific context, similar studies have shown promise in evaluating new treatments for advanced malignancies.

Eligibility criteria

Inclusion Criteria:

1. Sign written informed consent and be able to comply with the program's visit schedule and related procedures.
2. Male or female subjects, age 18\~75 years.
3. Histologically or cytologically confirmed advanced malignancy.
4. Subjects who have progressed on standard therapy, who are unsuitable for standard therapy, who do not have standard therapy, or who have refused standard therapy. For particular cohort, subjects who have not received prior systemic therapy for advanced disease.
5. At least one measurable lesion (target lesion) per RECIST v1.1.
6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
7. Life expectancy of 3 months or more.
8. Female subjects of childbearing age or male subjects whose partners are female subjects of childbearing age agree to strictly adopt effective contraceptive measures throughout the entire treatment period and 6 months after the treatment period.

Exclusion Criteria:

1. Women who are pregnant or lactating, or intending to become pregnant before, during, or within 6 months after the last dose of study drug.
2. Active or untreated CNS metastases confirmed by imaging evaluation during screening or previous imaging evaluation. Patients with asymptomatic brain metastases may participate in this study.
3. History of active thrombosis or deep vein thrombosis or pulmonary embolism within 4 weeks prior to the first dose of study drug.
4. Clinically significant cardiovascular or cerebrovascular disease.
5. Interstitial pneumonia, pulmonary fibrosis, pneumoconiosis, drug-associated pneumonia, and radiation pneumonitis requiring steroid hormone or other therapy, as well as history of severe abnormal lung function or other forms of restrictive lung disease.
6. History of allergies, asthma, atopic dermatitis.
7. Concomitant pleural or pericardial effusion requiring repeated drainage or with significant symptoms.
8. Active autoimmune disease requiring systemic therapy within 2 years prior to first dose.
9. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
10. Subjects with known or suspected hypersensitivity to the study drug and any excipients.
11. Subject has a prior history of significant toxicity associated with immune checkpoint inhibitor administration that requires permanent discontinuation.
12. Subjects with unresolved \> Grade 1 toxicity associated with any prior antineoplastic therapy, with the exception of persistent Grade 2 alopecia, peripheral neuropathy, hypomagnesemia, and toxicities that are not expected to be reversible but are stably controlled by medications (e.g., hypothyroidism stably controlled by substitution therapy, hypertension stably controlled by antihypertensive medications with a BP of less than 160/100 mmHg).
13. Inadequate recovery from previous surgery or any major surgery within 4 weeks prior to the first dose of study drug.
14. Active uncontrolled bleeding or known bleeding tendency.
15. Subject has a current or recent (within 6 months) major gastrointestinal disease or condition.
16. Subjects with uncontrolled tumor-related pain or symptomatic hypercalcemia.
17. Known positive HIV test, active hepatitis B, hepatitis C (HCV), tuberculosis.
18. Severe/active/uncontrolled infection, infection requiring systemic intravenous antibiotic therapy, or unexplained fever within 2 weeks prior to the first dose of study drug.
19. Diagnosis of another malignancy within 5 years prior to the first dose, exceptions include radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ, as well as post-radical localized prostate cancer, and papillary thyroid cancer.
20. Exclusion of contraindications to combination medications including, but not limited to: known contraindications to irinotecan therapy for the combination irinotecan or liposomal irinotecan cohort including, but not limited to: having the UGTA1\*6/\*6, UGT1A1\*28/\*28, or UGT1A1\*6/\*28 genotypes; history of prior pelvic and abdominal radiotherapy.
21. Presence of any disease, treatment or laboratory test abnormality, or history or current evidence of substance abuse that, in the judgment of the investigator, may compromise the safety of the subject, interfere with obtaining informed consent, affect subject compliance, or compromise the safety evaluation of the study drug.
22. Mental illness, presence of altered mental status, or substance abuse that prevents understanding of the informed consent process and/or completion of necessary study-related evaluations.
23. For known or foreseeable reasons, the Investigator believes that the subject is unable to fulfill the requirements of the protocol.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Chest Hospita — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Principal investigator: tingbo Liang, M.D. — The First Affiliated Hospital ZJ University
• Study coordinator: binbin Min

Conditions: Advanced Malignancies