Clinical Trials Actively Recruiting

Primary Objectives:

• To compare the ctDNA clearance proportion [i.e., ctDNA (+) → ctDNA (-)] at 12 weeks in patients enrolled in Cohort A treated with adjuvant nivolumab versus nivolumab + relatlimab (phase 2 portion)
• To compare overall survival in patients enrolled in Cohort A treated with adjuvant nivolumab versus nivolumab + relatlimab (phase 3 portion)
• To compare disease-free survival in patients enrolled in Cohort B randomized to immediate treatment with nivolumab to those randomized to surveillance with subsequent treatment with nivolumab only upon converting to ctDNA(+)

Secondary Objectives:

• To compare disease-free survival in patients enrolled in Cohort A treated with adjuvant nivolumab versus nivolumab + relatlimab.
• To define the association between ctDNA clearance and disease-free survival and overall survival for Cohort A patients.
• To compare overall survival in patients enrolled in Cohort B randomized to immediate treatment with nivolumab to those randomized to surveillance with subsequent treatment with nivolumab only upon converting to ctDNA(+).
• To determine the lead time from a ctDNA(+) assay to radiographic recurrence in patients initially ctDNA(-) post-definitive surgery enrolled in Cohort B.
• To estimate the proportion of Cohort B patients on Arm 4 who become ctDNA(+) and receive nivolumab.
• To compare the cumulative incidence of Cohort B patients who become ctDNA(+) between Arms 3 and 4.
• To determine the safety of adjuvant nivolumab plus relatlimab.

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 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.

Primary Objective:

• Assess the anti-tumour activity of zongertinib monotherapy in a variety of HER2-driven solid tumours

Secondary Objectives:

• Evaluate the efficacy, safety, tolerability, and risk-benefit profile of zongertinib
• Evaluate PROs

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.

Phase 1a dose escalation

Primary Objectives:

• To determine the MTD/MAD and evaluate the safety and tolerability of GSK5764227 in participants with advanced solid tumors.

Secondary Objectives:

• To evaluate the PK profile of GSK5764227 in participants with advanced solid tumors.
• To evaluate the clinical activity of GSK5764227 in participants with advanced solid tumors
• To evaluate the immunogenicity of GSK5764227 in participants with advanced solid tumors.To evaluate the immunogenicity of GSK5764227 in participants with advanced solid tumors.

Phase 1b dose expansion

Primary Objectives:

• To evaluate the clinical activity of GSK5764227 in participants with ES-SCLC or advanced solid tumors.

Secondary Objectives:

• To evaluate the safety and tolerability of GSK5764227 in participants with ES-SCLC or advanced solid tumors
• To evaluate additional measures of clinical benefit of GSK5764227 in participants with ES-SCLC or advanced solid tumors.
• To evaluate the PK profile of GSK5764227 in participants with ES-SCLC or advanced solid tumors.
• To evaluate the immunogenicity of GSK5764227 in participants with ES-SCLC or advanced solid tumors.