Open Actively Recruiting

A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors

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Brief Summary

KB707-01 is a Phase 1/2, open-label, multicenter, dose escalation and expansion study. The study will evaluate the safety and tolerability of KB707 in adults with locally advanced or metastatic solid tumors who have progressed on standard of care therapy, cannot tolerate standard of care therapy, refused standard of care therapy, or for whom there is no standard of care therapy as well as the safety, tolerability, preliminary efficacy, and immunologic effect of KB707 administered in combination with Opdualag to subjects with unresectable or metastatic melanoma.

Subjects in dose escalation (Cohorts 1 through 3) and dose expansion (Cohort 4) will receive intratumoral injections of KB707 approximately every three weeks. Cohorts 1 through 4 are closed to new enrollment. Dose expansion Cohort 5 will evaluate subjects with advanced melanoma. Subjects in Cohort 5 will receive intratumoral injections of KB707 biweekly (q2w), delivered in combination with Opdualag (dosed every q4w per prescribing information). All subjects will be treated until disease progression, death, unacceptable toxicity, symptomatic deterioration, achievement of maximal response, subject choice, Investigator decision to discontinue treatment, or the Sponsor determines to terminate the study.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 1

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Key Inclusion Criteria:

  • Histologically confirmed diagnosis of a locally advanced or metastatic solid tumor and the individual has progressed on standard of care therapy, cannot tolerate standard of care therapy, refused standard of care therapy, or there is no standard of care therapy.
  • Age 12 years or older at the time of informed consent
  • Life expectancy >12 weeks
  • ECOG performance status of 0 or 1
  • Have measurable disease per RECIST v1.1 at Screening
  • Histologically confirmed stage III (unresectable) or stage IV melanoma, as per American Joint Committee on Cancer (AJCC) staging system (8th edition; AJCC 2017)

Key Exclusion Criteria:

  • Prior surgery or radiation therapy must be fully recovered, including all radiation -related toxicities and subject does not require systemic corticosteroids
  • The subject is pregnant, nursing, or plans to become pregnant during study treatment and through three months after the last dose of KB707
  • Have known history of positive human immunodeficiency virus (HIV 1/2)
  • The subject must not have active brain metastases or leptomeningeal metastases
  • Subject has a known additional malignancy that is progressing or requires active treatment.
  • Prior anti-LAG-3/anti-PD-1 therapy was intolerable and required discontinuation of treatment
  • Subject has uveal/ocular melanoma

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Study Stats
Protocol No.
23-001294
Category
Head and Neck Cancer
Melanoma (Skin Cancer)
Other Cancer
Contact
Youstina Zaki
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT05970497
For detailed technical eligibility, visit ClinicalTrials.gov.