Clinical Trials Actively Recruiting

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:

• 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

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 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 (Dose Escalation)

Primary Objectives:

• To evaluate the safety and tolerability of DB-1311.
• To determine the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) of DB-1311.

Secondary Objectives:

• To assess the preliminary antitumor activity of DB-1311.
• To characterize the Pharmacokinetics (PK) of DB-1311 (DB-1311 antibodydrug conjugate [ADC], total anti- B7-H3 antibody, unconjugated payload P1021).
• To assess the immunogenicity of DB1311 in targeted subjects.

Phase 2a (Dose Expansion)

Primary Objectives:

• To assess the safety and tolerability of DB-1311 as monotherapy in targeted subject populations.
• To assess the effectiveness of DB-1311 as monotherapy by assessment of objective response rate (ORR) by investigator.

Secondary Objectives:

• To further assess the PK of DB-1311 (DB-1311 ADC, total anti-B7-H3 antibody, unconjugated payload P1021).
• To evaluate the prevalence and incidence of anti-drug antibody (ADA) against DB1311 in serum via a validated assay.
• To evaluate the preliminary efficacy of DB-1311 with additional efficacy parameters.

Part 1

Primary Objectives:

• To characterize the safety and tolerability of TEV-56278 in the trial population
• To determine a RP2D

Secondary Objectives:

• To characterize the serum pharmacokinetics of TEV-56278 in the trial population
• To evaluate the antitumor activity of TEV-56278 in the trial population

Part 2

Primary Objectives:

• To evaluate antitumor activity of TEV-56278 in the trial population

Secondary Objectives:

• To characterize the serum pharmacokinetics of TEV-56278 in the trial population
• To determine the safety and tolerability of TEV-56278 in the trial population
• To evaluate other measures of antitumor activity of TEV-56278 in the trial population

Primary Objectives:

• To compare DFS between Group A and Group B

Secondary Objectives:

• To compare TTNT (local or systemic) between study treatments
• To compare HG RFS between study treatments
• To compare PFS between study treatments
• To compare the rate of diagnostic and therapeutic invasive urological interventions after study treatment
• To assess safety and tolerability
• To compare OS between study treatments
• To compare participant-reported disease- and treatment-related symptoms and impacts on functioning between study treatments

Part I: Dose Escalation Phase

Primary Objectives:

• To evaluate the safety and tolerability of BGC515 Capsules in patients with malignant mesothelioma (MM), epithelioid hemangioendothelioma (EHE), or other advanced solid tumors.
• To explore the dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD).

Secondary Objectives:

• To evaluate the pharmacokinetics (PK) of BGC515 Capsules in patients with MM, EHE, or other advanced solid tumors.
• To preliminarily evaluate the efficacy of BGC515 Capsules in patients with MM, EHE, or other advanced solid tumors.

Part II: Dose Expansion Phase

Primary Objectives:

• To further evaluate the safety and tolerability of BGC515 Capsules in patients with MM, EHE, glioblastoma, or other advanced solid tumors including those with NF1/2 deficiency, YAP/TAZ fusion, LATS1/2 mutation, MST1/2 mutation, so as to determine the recommended phase 2 dose (RP2D).
• To evaluate the preliminary efficacy of BGC515 Capsules in patients with MM, EHE, glioblastoma, or other advanced solid tumors including those with NF1/2 deficiency, YAP/TAZ fusion, LATS1/2 mutation, MST1/2 mutation.

Secondary Objectives:

• To evaluate the PK of BGC515 Capsules in patients with MM, EHE, glioblastoma, or other advanced solid tumors including those with NF1/2 deficiency, YAP/TAZ fusion, LATS1/2 mutation, MST1/2 mutation.