New cancer drug trial halted early – what we know
NCT ID NCT05252390
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tested an experimental drug called NUV-868, alone or with other cancer drugs, in 82 adults with advanced solid tumors (including ovarian, pancreatic, prostate, and breast cancers). The goal was to find safe doses and check for early signs of effectiveness. However, the study was terminated early, so full results are not available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- NUV-868 (an experimental oral drug)
- What this could lead to
- If successful, this could point toward a new treatment option for advanced solid tumors like ovarian, pancreatic, prostate, or breast cancer.
- What could go wrong
- This was a very early (Phase 1/2) trial that was terminated, so results are limited. The drug may not prove effective or safe in larger studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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82 people
The number who actually took part.
- Started
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Mar 2022
- Finished
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Jul 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria For All Phases and Cohorts: 1. Recovered from toxicity to prior anticancer therapy 2. Adequate bone marrow and organ function 3. No known active or symptomatic central nervous system (CNS) disease Cohort-Specific Inclusion Criteria: In addition to the inclusion criteria listed above, the following criteria apply for enrollment into specific cohorts. Phase 1 (NUV-868 Monotherapy) 1. Patients with advanced solid tumors that have progressed during or after treatment with approved therapies or for which there is no standard effective therapy available 2. Life expectancy of \> 3 months 3. Eastern Cooperative Oncology Group Performance Status ≤ 2 4. Measurable or non-measurable disease Phase 1b (NUV-868 in Combination With Enzalutamide or Olaparib) 1. Life expectancy of \> 3 months 2. Eastern Cooperative Oncology Group Performance Status ≤ 2 3. (Select cohorts only) Measurable disease 4. Patient must be able to read and write sufficiently to document food intake and study drug dosing on the Dosing Diary or must have a caregiver who is willing and able to complete the Dosing Diary with the patient. 5. One of the following tumor types: 1. Ovarian: Platinum-resistant OR platinum-refractory high grade serous ovarian, fallopian, or primary peritoneal cancer in the relapsed setting 2. Pancreatic: Pancreatic ductal adenocarcinoma (PDAC) with progression on or after treatment with at least one line of systemic chemotherapy in the advanced setting 3. Prostate: Histologically confirmed, metastatic adenocarcinoma of the prostate (adenocarcinoma/high grade carcinoma with neuroendocrine features is allowed) with progression on or after treatment with at least one NHT in the metastatic setting 4. Breast: Triple-negative breast cancer (TNBC) with progression on or after treatment with at least one line of systemic chemotherapy in the advanced setting 5. Other advanced tumors (only Phase 1b dose escalation, NUV-868 + olaparib): the study Medical Monitor must approve enrollment. 6. For all tumor types: Patients will be allowed in the study regardless of their BRCA/HRR status. Phase 2 1. Life expectancy of \> 6 months 2. (Select cohorts only): At least one measurable lesion defined by standard criteria 3. Eastern Cooperative Oncology Group Performance Status ≤ 1 4. One of the following tumor types: 1. Ovarian: Platinum-resistant or platinum- refractory high grade serous ovarian, fallopian, or primary peritoneal cancer in the relapsed setting 2. Pancreatic: Progression on or after treatment with at least one line of systemic chemotherapy in the advanced setting 3. Prostate: Histologically confirmed, metastatic adenocarcinoma of the prostate (adenocarcinoma/high grade carcinoma with neuroendocrine features is allowed) with progression on or after treatment with at least one NHT in the metastatic setting 4. Breast: TNBC with progression on or after treatment with at least one line of systemic chemotherapy in the advanced setting Key Exclusion Criteria For All Phases and Cohorts: 1. Have received chemotherapy, hormonal therapy (except for ongoing luteinizing hormone-releasing hormone \[LHRH\] analogs in male patients and premenopausal women), radiation, or biological anticancer therapy within 14 days prior to the first dose of NUV-868. 2. Received treatment with an investigational agent for any indication within 14 days for non-myelosuppressive agent, or within 21 days or \< 5 half-lives (whichever is longer) for myelosuppressive agent, prior to the first dose of study treatment. 3. Requires medications that are known to be strong (or moderate for olaparib) inducers and/or strong (or moderate for olaparib) inhibitors of CYP3A4/5 enzymes. 4. Female patients who are pregnant of breastfeeding.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cabrini Hospital Malvern
Malvern, Victoria, 3144, Australia
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Calvary Mater Hospital Newcastle
Waratah, New South Wales, 2298, Australia
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Carolina BioOncology Institute
Huntersville, North Carolina, 28078, United States
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Ellison Institute of Technology
Los Angeles, California, 90064, United States
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Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19104, United States
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H. Lee Moffitt Cancer Center
Tampa, Florida, 33612, United States
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Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
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Laura & Isaac Perlmutter Cancer Center - NYU Langone Health
New York, New York, 10016, United States
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Linear Clinical Research
Nedlands, Western Australia, 6009, Australia
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Macquarie University Hospital
North Ryde, New South Wales, 2109, Australia
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Mary Crowley Cancer Research
Dallas, Texas, 75230, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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NEXT Virginia
Fairfax, Virginia, 22031, United States
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Peter Maccallum Cancer Centre
Melbourne, Victoria, 3000, Australia
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Rocky Mountain Cancer Centers, LLP
Aurora, Colorado, 80012, United States
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Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, 80124, United States
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Sarah Cannon Research Institute - Tennessee Oncology
Nashville, Tennessee, 37203, United States
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231, United States
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Texas Oncology - Fort Worth Cancer Center
Fort Worth, Texas, 76104, United States
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The University of Arizona Cancer Center
Tucson, Arizona, 85724, United States
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Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
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