KZR-261 in Subjects With Advanced Solid Malignancies
Colon/Rectal Cancer
Eye Cancer
Melanoma
Prostate Cancer
Solid Tumor
Unknown Primary
18 Years and older, Male and Female
KZR-261-101 (primary)
NCI-2022-01096
Summary
A first-in-human, open-label, multicenter, Phase 1 study of KZR-261 designed to assess the
safety and tolerability, preliminary anti-tumor activity, and pharmacokinetics (PK) of
KZR-261, as well as identify the recommended Phase 2 dose (RP2D). The study comprises a Part
1 (Dose Escalation) and a Part 2 (Dose Expansion) in solid organ tumors (melanoma/uveal
melanoma, mesothelioma, colorectal cancer, prostate cancer, and "All-Tumors").
Objectives
The first-in-human, open-label, multicenter, Phase 1 study of KZR-261, Study KZR-261-101,
will be conducted in two parts (dose escalation and dose expansion) to evaluate the safety
and tolerability, pharmacokinetics, pharmacodynamics, and evaluate the preliminary anti-tumor
activity of KZR-261 in subjects with locally advanced or metastatic solid malignancies for
whom no therapeutics are available that can confer a reasonable likelihood of clinical
benefit. The 5 tumor cohorts in the dose expansion part include advanced malignant:
- melanoma/uveal melanoma
- mesothelioma
- colorectal cancer
- castrate-resistant prostate cancer
- "All-Tumors"
Part 1 (Dose Escalation) and Part 2 (Dose Expansion) comprise a 4-week Screening Period, a
Treatment Period lasting approximately 24 weeks, 4-6-week Safety Follow-up, and a 12-month
Long-Term Follow-up Period (after last dose of study treatment), for a total study duration
of approximately 20 months.
Eligibility
- Histologic or cytologic evidence of malignant solid tumor with advanced disease (except primary central nervous system [CNS] neoplasms), defined as cancer that is either metastatic or locally advanced and unresectable (and for which additional radiation therapy or other locoregional therapies are not considered to result in reasonable clinical benefit).
- Disease that is resistant to or relapsed following available standard systemic therapy, or for which there is no standard systemic therapy or reasonable therapy in the Investigator's judgement likely to result in clinical benefit, or if such therapy has been refused by the subject. Documentation of the reason must be provided for subjects who have not received a standard therapy likely to result in clinical benefit.
- Eastern Cooperative Oncology Group Performance Status score of 0 or 1.
- Adequate baseline hematologic and organ function.
- Willing to use contraception.
Treatment Sites in Georgia
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