This study is seeking to determine the safety, effectiveness and recommended dose level of a new cancer drug (called NUV-868) when it is given alone, and when given in combination with other existing treatments, in people with advanced solid cancersPhase 1/2 Safety and Efficacy Study of NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors

Inclusion

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