NL-OMON53468
Recruiting
Not Applicable
A Phase I, first-in-human, multicenter, open-label, dose escalation followed by an expansion phase clinical study of KBA1412 given as monotherapy or in combination with pembrolizumab in adults with advanced solid malignant tumors - Study of KBA1412 in patients with advanced solid malignant tumors
Kling Biotherapeutics B.V.0 sites22 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- melanoma
- Sponsor
- Kling Biotherapeutics B.V.
- Enrollment
- 22
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female patients aged \>\=18 years with histologically and/or
- •cytologically confirmed locally advanced or metastatic solid tumors refractory
- •to standard therapy or for whom no standard therapy is available.
- •For Parts B and C, tumor types are initially restricted to melanoma, ovarian
- •cancer, gastric cancer, and colorectal. Any additional tumor types may be added
- •as defined by the SRC.
- •For Parts B and C, patients for whom anti\-PD\-1 or anti\-programmed cell death
- •ligand 1 (anti\-PD\-L1\) are the SOC should have progressed on these therapies
- •before being eligible for enrollment in Parts B and C. Patients cannot have
- •received more than one anti\-PD\-1 or anti\-PD\-L1 based regimen.
Exclusion Criteria
- •History of severe hypersensitivity reactions to other monoclonal antibodies.
- •Prior treatment with:
- •\- Any chemotherapy, anticancer small molecule therapy or investigational drug
- •or device within 14 days or 5 half\-lives (whichever is longer) prior to study
- •treatment administration.
- •\- Biological agents (including monoclonal antibodies) within 28 days prior to
- •study treatment administration.
- •\- Radiation, within 14 days prior to study treatment administration.
- •\- Treatment with nitrosoureas or mitomycin C require a 42\-day washout prior to
- •study treatment administration.
Outcomes
Primary Outcomes
Not specified
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