NCT06334432

A Phase 1/2, First-in-Human, Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors

Active, enrolled Phase 1/Phase 2 Last updated 12 January 2026

What this trial tests

Phase 1/Phase 2 trial testing NUV-1511 in Advanced Solid Tumor in 466 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

14 March 2024

Primary endpoint
1 March 2027

1 October 2027

Quick facts

Lead sponsor	Nuvation Bio Inc.
Phase	Phase 1/Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	466
Start date	14 March 2024
Primary completion	1 March 2027
Estimated completion	1 October 2027
Sites	8 locations across United States

Drugs / interventions tested

• NUV-1511 — full drug profile →

Conditions studied

• Advanced Solid Tumor — all drugs for Advanced Solid Tumor →
• HER2-negative Breast Cancer — all drugs for HER2-negative Breast Cancer →
• Metastatic Castration-resistant Prostate Cancer (mCRPC) — all drugs for Metastatic Castration-resistant Prostate Cancer (mCRPC) →
• Pancreatic Cancer — all drugs for Pancreatic Cancer →

Sponsor

Nuvation Bio Inc. — full company profile →

Who can join

18 and older, any sex, with Advanced Solid Tumor or HER2-negative Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Phase 1: Assess safety and tolerability of NUV-1511 in advanced solid tumors
  Time frame: First 28 days of dosing (DLT evaluation period)
  Number of patients with dose limiting toxicities, treatment emergent adverse events (TEAE) and serious adverse events (SAE) and laboratory abnormalities
• Phase 1: Identify recommended dosing schedule(s) and corresponding Phase 2 dose(s) (RP2D(s))
  Time frame: First 28 days of dosing (DLT evaluation period)
  Number of patients with DLTs, TEAEs and SAEs and laboratory abnormalities
• Phase 2: Evaluate the efficacy of NUV-1511 in advanced solid tumors and selected tumor type(s)
  Time frame: From date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
  Efficacy measures may include tumor assessments, as assessed by CT scans, PET/CT, whole body bone scan and MRI
• Phase 2: Confirm the optimal NUV-1511 dose level/schedule for further development
  Time frame: Periodic efficacy assessments from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
  Overall response rate per RECIST 1.1 (Composite response rate for mCRPC patients only, if enrolled in Phase 2)
• Phase 2: Confirm the optimal NUV-1511 target tumor types for further development
  Time frame: Periodic efficacy assessments from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
  Overall response rate per RECIST 1.1 (Composite response rate for mCRPC patients only, if enrolled in Phase 2)

Sponsor's own description

NUV-1511-01 is a first-in human, open- label, Phase 1/2 to evaluate the safety and efficacy of NUV-1511 in patients with advanced solid tumors. The Phase 1 portion include patients with advanced solid tumors and is designed to determine the safety and the tolerability of doses of NUV-1511. In Phase 2, NUV-1511 will be given to determine the efficacy of patients with advanced solid tumors.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.