Clinical Trials Actively Recruiting

Primary Objectives:

• To assess the safety and tolerability of BL-M07D1 in metastatic or unresectable HER2-expressing tumors
• To determine the MTD if reached or MAD and two or more RDEs of BL-M07D1

Secondary Objectives:

• To characterize the pharmacokinetics of BL-M07D1, total anti-HER2 antibody, and payload (Ed-04)
• To investigate the antitumor activity of BL-M07D1

Primary Objective:

• To characterize the safety and tolerability of MOMA-341 as monotherapy or in combination with chemotherapy or immunotherapies

Secondary Objectives:

• To identify the RP2D(s) and/or recommended optimization doses of MOMA-341 as monotherapy and in combination with chemotherapies or immunotherapies
• To characterize the PK profile of MOMA341 when administered as monotherapy and in combination with chemotherapies or immunotherapies
• To assess the effects of food on the PK parameters of MOMA-341 (for select participants only)
• To characterize the PK profile of irinotecan and its active metabolite SN-38 when administered in combination with MOMA341
• To characterize preliminary evidence of antitumor activity associated with MOMA341 as monotherapy or in combination with chemotherapies or immunotherapies

Primary Objective:

Dose-escalation and Dose-expansion Cohorts

• To determine the safety profile, maximum tolerable dose (MTD), minimally reproducible active dose (MRAD), and recommended dose range (RDR) of BHV-1530 administered by IV infusion dosed Q3W.

Dose-confirmation Cohorts

• To determine the recommended dose (RD) of BHV-1530 for later phase trials.

Secondary Objectives:

Dose-escalation and Dose-expansion Cohorts

• To assess the preliminary efficacy of BHV-1530
• To determine the PK of BHV-1530, total antibody, and free payload TopoIx (BHC-0080269)
• To assess the incidence of antidrug antibody (ADA) against BHV-1530

Dose-confirmation Cohort

• To assess the preliminary efficacy of BHV-1530
• To determine the PK of BHV-1530, total antibody, and free payload TopoIx BHC-0080269
• To assess the incidence of ADA against BHV-1530

Phase 1a Escalation

Primary Objectives:

• To evaluate the safety and tolerability of OPB-101 delivered intravenously, including dose-limiting toxicities(DLTs)
• To determine the maximum tolerated dose (MTD) of OPB-101 and/or recommended Phase 1b dose(s)

Secondary Objectives:

• To characterize the cellular kinetic profile of OPB-101
• To assess preliminary anti-tumor activity of OPB-101

Phase 1b Expansion

Primary Objectives:

• To determine the recommended phase 2 dose (RP2D)
• To evaluate the anti-tumor activity of OPB-101
• To further evaluate the safety and tolerability of OPB-101

Secondary Objectives:

• To further characterize the cellular kinetic profile of OPB-101

Primary Objectives:

• Cohort A: To determine the efficacy of the combination of N-803 plus BCG compared to BCG alone in patients with CIS disease (with or without Ta/T1) in terms of complete response (CR) rate at 6 months using cystoscopy, confirmatory bladder biopsy (if required), and urine cytology;
• Cohort B: To determine the efficacy of the combination of N-803 plus BCG compared to BCG alone in patients with high-grade papillary disease (Ta/T1 only) in terms of disease-free survival (DFS) using cystoscopy, confirmatory bladder biopsy (if required), and urine cytology.

Secondary Objectives:

Cohort A

• To assess the safety profile of patients treated with N-803 plus BCG compared to patients treated with BCG alone.
• To assess the duration of CR of patients treated with N-803 plus BCG compared to patients treated with BCG alone.
• To assess the CR rate and duration of CR (all recurrent bladder cancer including low grade Ta disease) of patients treated with N-803 plus BCG compared to patients treated with BCG alone.
• To assess PFS for patients treated with N-803 plus BCG compared to patients treated with BCG alone.
• To assess the overall survival (OS) for patients treated with N-803 plus BCG compared to patients treated with BCG alone.
• To assess the disease-specific survival (DSS) for patients treated with N-803 plus BCG compared to patients treated with BCG alone.
• To assess the time to disease worsening for patients treated with N-803 plus BCG compared to patients treated with BCG alone.
• To assess the cystectomy-free rate for patients treated with N-803 plus BCG compared to patients treated with BCG alone.
• To assess the QoL of patients treated with N-803 plus BCG compared to patients treated with BCG alone.
• To assess the long-term CR rate (as determined by the Investigator) following completion of QUILT-2.005 phase 2b.

Cohort B

• To assess the safety profile of patients treated with N-803 plus BCG compared to patients treated with BCG alone.
• To assess the DFS rate at 3, 9, 12, 18, 24, 30, and 36 months of patients treated with N803 plus BCG compared to patients treated with BCG alone.
• To assess the DFS (all recurrent bladder cancer, including low grade Ta disease) of patients treated with N-803 plus BCG compared to patients treated with BCG alone.
• To assess PFS for patients treated with N-803 plus BCG compared to patients treated with BCG alone.
• To assess the OS for patients treated with N-803 plus BCG compared to patients treated with BCG alone.
• To assess the DSS for patients treated with N-803 plus BCG compared to patients treated with BCG alone.
• To assess the time to disease worsening for patients treated with N-803 plus BCG compared to patients treated with BCG alone.
• To assess cystectomy-free rate for patients treated with N-803 plus BCG compared to patients treated with BCG alone.
• To assess the QoL of patients treated with N-803 plus BCG compared to patients treated with BCG alone.
• To assess long-term DFS (as determined by the Investigator) since the randomization in QUILT-2.005 phase 2b.

Cohorts A and B

• To obtain yearly LTFU data from subjects who were treated in QUILT-2.005 phase 2b for a maximum of 10 years.

Primary Objective:

• To evaluate the efficacy of fosmanogepix for the treatment of adult patients with IMis caused by Aspergillus spp. (in patients with limited treatment options), Fusarium spp., Lomentospora prolificans, Mucorales fungi, or other multidrug resistant molds

Secondary Objectives:

• To evaluate the efficacy of fosmanogepix for the treatment of adult patients with IMis caused by Aspergillus spp. (in patients with limited treatment options), Fusarium spp., Lomentospora prolificans Mucorales fungi,, or other multidrug resistant molds

• To evaluate the safety and tolerability of IV and oral fosmanogepix

• To evaluate the PK of fosmanogepix (prodrug) and manogepix (active moiety)

Primary Objective:

De-Intensification Study:

• To determine whether men with National Comprehensive Cancer Network (NCCN) unfavorable intermediate risk (UIR) prostate cancer and lower Decipher genomic risk (Decipher score < 0.40) treated with RT alone instead of 6 months ADT + RT experience non-inferior rate of distant metastasis.

Intensification Study:

• To determine whether men with NCCN UIR prostate cancer who are in the higher genomic risk (Decipher score ≥0.40) will have a superior metastasis-free survival through treatment intensification with darolutamide added to the standard of RT plus 6 months ADT.

Secondary Objectives:

• To compare overall survival (OS) between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.
• To compare time to PSA failure between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.
• To compare metastasis free survival (MFS) based on conventional imaging between the standard of care (RT plus 6 months of ADT) and de-intensification intervention (RT alone).
• To compare MFS based on either conventional and/or molecular imaging between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.
• To compare cumulative incidence of locoregional failure based upon conventional imaging and/ or biopsy between standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months ADT plus darolutamide) interventions.
• To compare cumulative incidence of distant metastasis based upon conventional imaging between standard of care (RT plus 6 months of ADT) and intensification intervention (RT plus 6 months ADT plus darolutamide).
• To compare cumulative incidence of distant metastasis based upon either conventional and/or molecular imaging between standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.
• To compare prostate cancer-specific mortality between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.
• To compare sexual and hormonal related quality of life, as measured by the Expanded Prostate Cancer Index Composite-26 (EPIC), between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.
• To compare fatigue, as measured by the PROMIS-Fatigue instrument, between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.
• To compare cognition, as measured by the Functional Assessment of Chronic Illness Therapy-Cognitive (FACT-Cog) perceived cognitive abilities subscale, between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.

Primary Objectives:

• Addressing the unmet medical need caused by the acute BCG shortage
• Recombinant Mycobacterium Bacillus Calmette Guérin Strain for Immunotherapy (rMBCG)

Primary Objectives:

Phase 1: Dose Escalation

• To characterize the safety, tolerability, and dose-limiting toxicities (DLTs), and determine the recommended Phase 2 dose (RP2D) of STAR0602

Phase 2: Dose Expansion

• To further explore anti-tumor activity of STAR0602 in unresectable, locally advanced, or metastatic solid tumors

Secondary Objectives:

Phase 1: Dose Escalation

• To evaluate preliminary antitumor activity of STAR0602 in unresectable, locally advanced, or metastatic solid tumors
• To evaluate the PK profile of STAR0602 in serum after single and repeated IV infusions

Phase 2: Dose Expansion

• To further evaluate the antitumor activity of STAR0602
• To evaluate the PK profile of STAR0602 in serum after single and repeated IV infusions
• To further characterize the safety and tolerability of STAR0602

Phase 1 and Phase 2: Dose Escalation and Dose Expansion

• To assess antidrug antibody (ADA) formation after IV single and repeat dose administration of STAR0602

PHASE 1

Primary Objectives:

• Assess safety and tolerability of NUV‑1511 in advanced solid tumors
• Identify recommended dosing schedule(s) and corresponding RP2D(s) for Phase 2

Secondary Objectives:

• Explore preliminary efficacy of NUV-1511
• Characterize the PK profiles of NUV-1511

PHASE 2

Primary Objectives:

• Evaluate the efficacy of NUV-1511 in advanced solid tumors and selected tumor type(s)
• Confirm the optimal NUV-1511 dosing schedule, dose level, and target tumor types for further development

Secondary Objectives:

• Further evaluate the safety and efficacy of NUV-1511