Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Clinical summary
Summary
This is a Phase 1, multicenter, 2-part study with a Dose-Escalation Segment and Dose and Disease Expansion Cohort of CBT-501 injection, a humanized IgG4 monoclonal antibody, targeting the Programmed Death-1 (PD-1) membrane receptor on T lymphocytes and other cells of the immune system. Select advanced solid tumor malignancies will receive escalating doses of CBT-501. Dose escalation will occur in three subject cohorts until a protocol defined dose limited toxicity (DLT) occurs, not due to disease progression or inter-current illness, and a tentative maximum tolerated dose (MTD) is determined. At the tentative MTD or recommended Phase 2 dose (RP2D), at least two tumor types will be assessed to further evaluate toxicity and preliminary efficacy
Conditions
This trial is treating people with advanced cancers (excluding blood cancer)
Eligibility
Inclusion
• Able to understand and comply with study procedures, understand the risks involved, and provide written informed consent.
Dose Escalation:
- Histologically and / or cytological confirmed solid tumors: colorectal, endometrial, gastric including, gastroesophageal junction adenocarcinoma (GC), head and neck (esophageal, hepatocellular (HCC), non-small cell lung cancer, mesothelioma, ovarian, and renal cell carcinoma (RCC), either refractory or relapsed to standard therapy or for which no effective standard therapy is available.
- No restriction to number of prior therapies for Dose Escalation Segment except for gastric and renal cell carcinoma.
Cohort Extension:
- Histologically and/or cytological confirmed solid tumors with an approved labelled indication for PD-1 inhibitors.
- Tumor biopsy at study entry and during therapy. Tumor sites used to satisfy this criterion must not have received any prior radiation therapy. Sites for biopsy must be distinct from target lesions used for efficacy assessment.
- Measurable disease according to RECIST v1.1.
Dose and Disease Expansion:
- MSI-H or dMMR per local laboratory and failed at least one prior line of standard of care chemotherapy per local standards.
- Carcinoma of Unknown Primary
Exclusion
- History of severe hypersensitivity to mAbs, excipients of the drug product or other components
- Prior malignancy active within the previous 2 years except for locally curable cancers that have been cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast
- Any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, except for subjects with vitiligo or resolved childhood asthma/atopy
- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibody (or any other antibody targeting T cell co-stimulation pathways) (except NSCLC)
- Known significant mental illness or other conditions such as active alcohol or other substance abuse that, in the opinion of the Investigator, predisposes the subject to high risk of noncompliance with the protocol treatment or assessments.
Inclusion
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Apollomics Inc
Scientific Title
A Phase 1 Multicenter, Dose Escalation Study of CBT-501 in Subjects With Select Advanced or Relapsed/Recurrent Solid Tumors
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