To evaluate overall response rate (ORR) as assessed by Independent Central Review (ICR) using RECIST v1.1

This endpoint was not assessed due to early study termination. Due to early study termination, data was not submitted for independent central review and therefore the overall response rate was done according to investigator assessment only and no independent central review was performed.

To evaluate duration of response (DOR) as assessed by ICR using RECIST v1.1

This endpoint was not assessed due to early study termination. Due to early study termination, data was not submitted for independent central review and therefore the DOR was done according to investigator assessment only and no independent central review was performed.

To evaluate progression-free survival (PFS) as assessed by ICR using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

This endpoint was not assessed due to early study termination. Due to early study termination, data was not submitted for independent central review and therefore the PFS was done according to investigator assessment only and no independent central review was performed.

To evaluate ORR as defined as the proportion of patients who had a partial or complete response (PR or CR) to therapy, as assessed by Investigator using RECIST v1.1 and assessed periodically throughout the treatment period based on imaging every 8 weeks (56 ± 7 days).

This population consisted of all patients (12 out of 22 patients) with measurable disease who received at least 1 dose of study treatment, who had an adequate baseline tumor assessment, and at least 1 follow-up tumor assessment considered evaluable for anti-tumor efficacy using RECIST v1.1 criteria.

To evaluate DOR as assessed by Investigator using RECIST v1.1 defined as from first documentation of objective tumor response (CR or PR) to first documentation of objective tumor progression or death due to any cause.

This population consisted of all patients (2 patients with CR or PR out of the 12 evaluable for response, out of 22 total patients) with measurable disease who received at least 1 dose of study treatment, who had an adequate baseline tumor assessment, and at least 1 follow-up tumor assessment considered evaluable for anti-tumor efficacy using RECIST v1.1 criteria.

To evaluate PFS as assessed by Investigator using RECIST v1.1 determined from the first dose to the date of first radiographic progression or death from any cause in the absence of progression, whichever occurred first, or were censored.

This population consisted of all patients (12 out of 22 patients) with measurable disease who received at least 1 dose of study treatment, who had an adequate baseline tumor assessment, and at least 1 follow-up tumor assessment considered evaluable for anti-tumor efficacy using RECIST v1.1 criteria.

To evaluate Clinical Benefit Rate (CBR), defined as the percentage of patients who had achieved Complete Response (CR), Partial Response (PR), or Stable Disease (SD) for 8 weeks or more, as assessed by Investigator only (ICR not performed due to early study termination).

Due to early study termination, data was not submitted for independent central review and therefore the CBR was done according to investigator assessment only and no independent central review. This population consisted of all patients (12 out of 22 patients) with measurable disease who received at least 1 dose of study treatment, who had an adequate baseline tumor assessment, and at least 1 follow-up tumor assessment considered evaluable for anti-tumor efficacy using RECIST v1.1 criteria.

To evaluate intracranial ORR in participants with untreated measurable CNS lesions as assessed by Investigator using RECIST v1.1

This endpoint was not assessed due to early study termination. Intracranial ORR in patients with untreated measurable CNS was not measured.

To evaluate intracranial ORR in participants with untreated measurable CNS lesions as assessed by ICR using RECIST v1.1

This endpoint was not assessed due to early study termination. Due to early study termination, data was not submitted for independent central review and therefore the ORR with untreated measurable CNS lesions was not evaluated by independent central review.

To evaluate safety and tolerability per the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0)

The Safety Population consisted of all 22 enrolled patients who took at least 1 dose of study drug.

To evaluate overall survival (OS) defined as the time from the date of first dose of study drug to the date of death by any cause. Patients who were alive were censored at the date of last contact.

This population consisted of all patients (12 out of 22 patients) with measurable disease who received at least 1 dose of study treatment, who had an adequate baseline tumor assessment, and at least 1 follow-up tumor assessment considered evaluable for anti-tumor efficacy using RECIST v1.1 criteria.