A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of XmAb®662 in Monotherapy or in Combination With Pembrolizumab in Advanced Solid Tumors
A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of XmAb®662 in Monotherapy or in Combination With Pembrolizumab in Advanced Solid Tumors
NCT #
NCT05996445
Condition(s)
Solid Tumors
Molecular Target(s)
IL-12
Drug Classification(s)
Monoclonal Antibody
Agents(s)
XmAb662
Phase(s)
I
Mechanism of Action
XmAb662 is a IL-12 Recombinant fusion protein
Purpose
- How much of the study agent can be given with an acceptable level of side effects• The effects of the study agent (good and bad)
- How much of the study agent is absorbed into the blood and how fast it is removed
- How the study agent is acting in your body.
- Advanced, recurrent or metastatic solid malignancy that is not amenable to curative-intent treatment and which has progressed after standard therapy appropriate for the following tumor type: Head and neck squamous cell carcinoma, melanoma, non-small cell lung cancer, small cell lung cancer (SCLC), urothelial carcinoma, colorectal cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal cell carcinoma, endometrial cancer, cutaneous squamous cell carcinoma, breast cancer, ovarian cancer (epithelial), castration-resistant prostate cancer (adenocarcinoma)
- Measurable disease by RECIST 1.1; subjects with prostate cancer who have evaluable disease according to PCWG3 criteria may enroll
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- For dose escalation cohorts, subjects must have adequate archival tumor sample or willing to provide a fresh tumor
- Adequate organ function
- Receiving treatment with the following therapies: Interleukin (IL)-12 either alone or as part of a treatment regimen; checkpoint inhibitors given within 4 weeks of study drug; other anticancer therapies, including chemotherapy or radiation therapy, given within 4 weeks of the start of study drug (palliative radiation given within a 1-week washout is allowed)
- History of allergic or anaphylactic/hypersensitivity reaction to immunotherapy
- History of a life-threatening (Grade 4) immune-related adverse event (irAE) related to prior immunotherapy or any prior irAE, regardless of grade
- History or evidence of any clinically unstable/uncontrolled disorder, condition, or disease (including, but not limited to, cardiopulmonary, renal, metabolic, hematologic, or psychiatric) other than their primary malignancy
- Known active central nervous system involvement by malignant disease; subjects with previously treated brain metastases may participate provided they are radiologically and clinically stable
- For subjects receiving pembrolizumab, prior Grade 3 or Grade 4 infusion-related reactions to pembrolizumab, or known hypersensitivity to pembrolizumab
- Other protocol defined inclusion/exclusion criteria apply
No restrictions
Location
MCD
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