Advanced Solid Tumors

BridgeBio Enters into Clinical Collaboration with BMS to Evaluate BBP-398 + Opdivo for Advanced Solid Tumors with KRAS Mutations

Shots: The companies will initiate P-I/II study evaluating the safety and preliminary efficacy of BBP-398 in combination with both Opdivo as dual therapy & Opdivo + KRASG12C inhibitor as triplet therapy in NSCLC patients with KRAS mutations, as 1L & 2L treatment options BridgeBio will sponsor the study while BMS will provide nivolumab to the …

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Hutchmed Initiates P-I Trial of HMPL 295 for the Treatment of Advanced Solid Tumors in China

Shots: The company has initiated a P-I open-label study to evaluate the safety, tolerability, PK & preliminary efficacy of HMPL-295 & to determine MTD and RP2D in patients with advanced malignant solid tumors. The 1st patient has been dosed on 02 Jul, 2021 Following the initial dose-escalation stage, 10 to 15 patients will enroll at …

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Bayer Seeks Approval of Larotrectinib for Advanced Solid Tumors in China

Shots: The NDA submission is based on P-I study of adult patients, the P-II NAVIGATE trial in adult and adolescent patients and the P- I/II pediatric SCOUT trial. These trials evaluated Larotrectinib in 20+ different histologies of solid tumors with NTRK fusion The therapy is already approved in several countries under the brand name Vitrakvi, …

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Exelixis Reports the US FDA’s Acceptance of IND for XB002 in Patients with Advanced Solid Tumors

Shots: The US FDA has accepted IND to assess the safety, tolerability, PK, and preliminary antitumor activity of XB002 in patients with advanced solid tumors. The P-I trial is expected to initiate in Q2’21 The preclinical data demonstrated that XB002 binds to tissue factors without affecting the coagulation cascade, in contrast with prior therapies in …

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Strata Oncology Collaborates with Mirati Therapeutics to Broaden Enrollment in Clinical Trial of MRTX849 for Patients with Advanced Solid Tumors

Shots: The multiple expansion cohort will assess the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 in patients with advanced solid tumors harboring a KRAS G12C mutation Strata Oncology will identify patients to be considered for enrollment into Mirati’s P-I/II study. The Strata Trial provides tumor molecular profiling for patients with advanced …

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