OncoMatch/Clinical Trials/NCT05970497
A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors
Is NCT05970497 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including KB707 and Opdualag for cancer.
Treatment: KB707 · Opdualag · KEYTRUDA ®( Pembrolizumab) — 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 and Cohort 6 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). Subjects in Cohort 6 will receive intratumoral injections of KB707 biweekly (q2w), delivered in combination with Keytruda (dosed every q6w 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Biomarker criteria
Allowed: BRAF V600 mutation
If proto-oncogene B-Raf (BRAF) V600 mutation-positive, subject previously failed a BRAF inhibitor or BRAF inhibitor in combination with ... MEK inhibitor
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1 therapy — unresectable or metastatic melanoma
Subject has previously failed one prior anti-PD-1/PD-L1 treatment (as monotherapy or in combination with other checkpoint inhibitors such as anti-LAG-3 or anti-CTLA-4)
Must have received: BRAF inhibitor — if BRAF V600 mutation-positive
If proto-oncogene B-Raf (BRAF) V600 mutation-positive, subject previously failed a BRAF inhibitor or BRAF inhibitor in combination with ... MEK inhibitor
Cannot have received: systemic therapy
Exception: no more than 2 lines for unresectable or metastatic melanoma
Subject has received more than 2 lines of systemic therapy for unresectable or metastatic melanoma
Cannot have received: anti-LAG-3 and/or anti-PD-1 therapy
Exception: if prior therapy was intolerable and required discontinuation
Prior anti-LAG-3 and/or anti-PD-1 therapy was intolerable and required discontinuation of treatment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UCLA Health · Los Angeles, California
- Mission Dermatology Center · Rancho Santa Margarita, California
- BRCR Global · Weston, Florida
- IU Simon Comprehensive Cancer Center · Indianapolis, Indiana
- Henry Ford Cancer Institute · Detroit, Michigan
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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