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A Phase 1/2 Open-label Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of ARV-6723 Administered as Monotherapy and in Combination with Pembrolizumab in Participants with Advanced Solid Tumors

Status
Not yet recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-525614-57-00
Enrollment
60
Registered
2026-10-22
Start date
Unknown
Completion date
Unknown
Last updated
2026-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Cancer

Brief summary

Part A1: First cycle dose-limiting toxicities., Part A1: AEs as characterized by type, frequency, severity (as graded by NCI CTCAE v6.0), timing, seriousness and relationship to study intervention., Part A1: Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v6.0), and timing., Part A2: AEs as characterized by type, frequency, severity (as graded by NCI CTCAE v6.0), timing, seriousness, and relationship to study intervention, Part A2:Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v6.0), and timing, Part A2: Preliminary antitumor activity: ORR by CT/MRI using RECIST 1.1 criteria per investigator assessment

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGARV-6723
DRUGKEYTRUDA 395 mg solution for injection

Sponsors

Arvinas Operations Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Part A1: First cycle dose-limiting toxicities., Part A1: AEs as characterized by type, frequency, severity (as graded by NCI CTCAE v6.0), timing, seriousness and relationship to study intervention., Part A1: Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v6.0), and timing., Part A2: AEs as characterized by type, frequency, severity (as graded by NCI CTCAE v6.0), timing, seriousness, and relationship to study intervention, Part A2:Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v6.0), and timing, Part A2: Preliminary antitumor activity: ORR by CT/MRI using RECIST 1.1 criteria per investigator assessment—

Outcome results

None listed

Source: EU CTIS · Data processed: Oct 23, 2026