FDA Clears IND of NUV-1511 for Advanced Solid Tumors


NUV-1511, a novel drug candidate for the treatment of solid tumors, has received clearance from the FDA for its investigational new drug application.

  • Following the FDA clearance, a phase 1/2 clinical trial of NUV-1511 is scheduled to commence in the first half of 2024.

  • The clearance expands Nuvation Bio's clinical pipeline and validates the effectiveness of its proprietary drug-drug conjugate (DDC) platform.

  • NUV-1511, the first clinical candidate from Nuvation Bio's DDC platform, is being developed for patients with advanced solid tumors.

An investigational new drug (IND) application to evaluate NUV-1511 for the treatment of solid tumors has been cleared by the FDA.1 With this IND clearance, a phase 1/2 clinical study of NUV-1511 plans to begin the first half of 2024.

“This IND clearance expands our clinical pipeline and validates the approach of our proprietary DDC platform to design potent oncology-focused chimeric small molecules which combine tumor-targeting specificity with the anti-cancer activity of known oncology agents,” said David Hung, MD, founder, president, and chief executive officer of Nuvation Bio, in a press release.

NUV-1511 is the first clinical candidate from Nuvation Bio’s novel DDC platform. The DDC program is a small molecule platform that uses a novel therapeutic approach within the drug-conjugate class of anti-cancer therapies. The design of the platform works to selectively deliver potent anti-cancer therapies to cancer cells, employing a greater toxicity to combat and target these tumor cells and not healthy, non-target tissues.2

The agent is under development for patients with advanced solid tumors following treatment with fam-trastuzumab-deruxtecan-nxki (Enhertu) and/or post progression from sacituzumab govitecan-hziy (Trodelvy), HER2-negative metastatic breast cancer (mBC), metastatic castration-resistant prostate cancer (mCRPC), pancreatic cancer, and platinum-resistant ovarian cancer (PROC).

Initially, the dose-escalation of this phase 1/2 study will evaluate the safety, tolerability, and clinical efficacy of NUV-1511.1 Patients with advanced solid tumors who previously received and progressed on or after treatment with trastuzumab-deruxtecan and/or sacituzumab govitecan, HER2-negative mBC, mCRPC, pancreatic cancer, and PROC will be enrolled.

“We believe NUV-1511 has the potential to provide favorable clinical benefit for patients with various solid tumors and we look forward to initiating the phase 1/2 study,” explained Hung, in a press release.1

  1. Nuvation Bio announces FDA clearance of investigational new drug application for NUV-1511 for the treatment of advanced solid tumors. News release. Nuvation Bio Inc. January 8, 2024. Accessed January 9, 2024. http://tinyurl.com/y32zauxk
  2. Pipeline. Nuvation Bio Inc. Accessed January 9, 2024. https://www.nuvationbio.com/pipeline/
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