First-in-Human Study of IMGC936 in Patients With Advanced Solid Tumors
- Conditions
- Advanced Solid TumorsMedDRA version: 20.0Level: LLTClassification code 10079440Term: Non-squamous non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10075566Term: Triple negative breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: LLTClassification code 10056267Term: Gastroesophageal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10061451Term: Colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: LLTClassification code 10033604Term: Pancreatic cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-002264-41-ES
- Lead Sponsor
- ImmunoGen, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 250
1. Ability to provide informed consent and documentation of informed consent prior to any study-related tests or procedures that are not part of standard of care for the participant’s disease. Participants must be willing and able to comply with study procedures.
2. Participants with histologically proven, relapsed or refractory, unresectable locally advanced or metastatic non-squamous NSCLC, TNBC, CRC, gastroesophageal cancer, or pancreatic cancer for whom no therapy with demonstrated clinical benefit is available.
Note: Neoadjuvant/adjuvant systemic treatment are included in prior lines of therapy, except for TNBC where they are excluded.
Note: Maintenance therapies are considered part of the prior line of therapy and will not be counted as a separate line of therapy.
a. NSCLC: Participants must have been treated with 1 to 4 prior lines of systemic therapy with no more than 2 chemotherapy containing lines.
b. TNBC: Participants must have been treated with 1 to 4 prior lines of systemic therapy for metastatic disease, excluding adjuvant therapies.
c. CRC: Participants must have been treated with 1 to 3 prior lines of systemic therapy.
d. Gastroesophageal cancer: Participants must have been treated with 1 to 3 prior lines of systemic therapy.
e. Pancreatic cancer: Participants must have been treated with 1 to 3 prior lines of systemic therapy, with no more than 2 chemotherapy containing lines.
3. Either non-measurable or measurable disease per RECIST v1.1 and documented by CT and/or MRI obtained within 28 days of C1D1.
a. Dose Escalation Phase: Participants may have non-measurable or measurable disease per RECIST v1.1.
b. Dose Expansion Phase: Participants must have measurable disease per RECIST v1.1.
4. Age > or = 18 years old.
5. Archival FFPE tissue must be available. Participants may undergo a fresh tumor biopsy using a low-risk, medically routine procedure to obtain a specimen for testing if a archival tumor sample is not available.
a. Tumor specimens for retrospective determination of ADAM9 expression via IHC staining will be collected from all participants and will be assayed at a central laboratory designated by the sponsor.
6. ECOG performance status of 0 or 1.
a. If ECOG performance status is an inappropriate performance measurement for participant enrollment (eg, chronically non-ambulatory), then Karnofsky performance status must be > or = 70.
7. Life expectancy > or = 12 weeks.
8. Acceptable laboratory parameters as follows:
• Platelet count > or = 75 × 1^3/microL without platelet transfusion within 28 days prior to initiation of study drug.
• Absolute neutrophil count > or = 1.5 × 1^3/microL in the absence of any growth factor support within 21days prior to initiation of study drug.
• ALT/AST < or = 3.0 × ULN; for participants with hepatic metastases, ALT and AST < or = 5 × ULN.
• Total bilirubin = 1.5 × ULN, except participants with Gilbert’s syndrome, who may enroll if the conjugated bilirubin is within normal limits.
• eGFR > 30 mL/min/1.73 m^2 or an estimated creatinine clearance of > 30 mL/min.
• Urinalysis protein and white occult blood cells within normal limits.
• Negative serum pregnancy test for FOCBP.
9. FOCBP, defined as not surgically sterilized (hysterectomy, bilateral salpingectomy, and
bilateral oophorectomy) and between menarche and 1-year post menopause, must have a
negative serum pregnancy test performed within 72 hours prior to initiation of study drug
administration. Female participants must abstain f
1. Participants with active central nervous system (CNS) disease within the last 6 months.
2. Active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and/or monocular vision.
3. Participants who had prior therapies within the specified times below:
• Systemic antineoplastic therapy within at least 5 half-lives or 4 weeks (whichever is shorter) prior to initiation of study drug.
• Mediastinal or pelvic radiation therapy within 6 weeks prior to initiation of study drug administration. Palliative, limited field radiation for symptom control to soft tissues, or bone lesions within 2 weeks prior to initiation of study drug.
- Note: Previously irradiated lesions are not considered measurable disease unless they have demonstrated progression per RECIST v1.1.
4. Participants must have stabilized or recovered (Grade 1 or baseline) from all priortherapy-related toxicities (except alopecia).
5. Clinically significant cardiovascular disease including but not limited to:
• Myocardial infarction or unstable angina within 6 months prior to initiation of study drug.
• Stroke or transient ischemic attack within 6 months prior to initiation of study drug.
• Current clinically significant cardiac arrhythmias, eg, atrial fibrillation that are not well controlled with optimal medical intervention.
• Current uncontrolled hypertension: systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg.
• Current congestive heart failure (New York Heart Association class III-IV).
• Current pericarditis or clinically significant pericardial effusion.
• Current myocarditis.
• LVEF of < 50% by scan.
• QTc interval > 480 msec.
6. Clinically significant pulmonary compromise, including pneumonia, pneumonitis, or a requirement for supplemental oxygen (excluding for sleep apnea) or history of = Grade 3 drug-induced or radiation pneumonitis.
7. Participants with serious concurrent illness or clinically relevant active infection, including, but not limited to the following:
• Active hepatitis B or C infection (whether or not on active antiviral therapy).
• Human immunodeficiency virus infection.
• Cytomegalovirus infection.
• Active COVID-19/SARS-CoV-2 infection. While SARS-CoV-2 testing is not mandatory for study entry, testing should follow local clinical practice guidelines/standards.
• Any other concurrent infectious disease requiring IV antibiotics within 2 weeks prior to initiation of study drug.
Note: Testing at screening is not required for the above infections unless clinically indicated.
8. History of prior bone marrow, stem cell, or solid organ transplantation.
9. Second primary invasive malignancy that has not been in remission for greater than 2 years, except nonmelanoma skin cancer; cervical carcinoma in situ on biopsy; or squamous intraepithelial lesion on Pap smear; localized prostate cancer (Gleason score < 6); or resected melanoma in situ or similar.
10. Major trauma or major surgery within 4 weeks prior to initiation of study drug.
11. Any serious underlying medical or psychiatric condition that would impair the ability of the participant to receive or tolerate the planned treatment at the study site.
12. Prior life-threatening hypersensitivity reactions to antibodies
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method