This is a multi-center, Phase 1 / 2 clinical study for patients with advanced solid tumors.
The study consists of 2 treatment arms - a monotherapy arm and a combination arm. The
monotherapy arm has 1 part: Dose Escalation (Part A) The combination arm has Dose Escalation
(Part B) only.
The primary objective of Part A in the monotherapy arm is to determine the RP2D of DSP-0509
when administered as a single agent. Approximately 21 to 30 patients with advanced solid
tumors will be enrolled. At the time of this amendment, 12 patients have been enrolled in the
monotherapy cohorts with dose levels of 0.3, 1, and 1.5 mg DSP-0509 given once per week and
completed the DLT period. Based on review of DLTs and consistent with the BLRM model, the
Safety Review Committee has assessed that continuing at the 1.5 mg dose level is appropriate.
Under Protocol Amendment 4, the dose level of 1.5 mg given every two weeks will be applied in
Monotherapy Part A. Enrollment of additional cohorts will be based on the dose escalation
The primary objective of Combination Part B is to determine the RP2D of DSP-0509 when
administered in combination with pembrolizumab, using a BLRM approach as described above. The
combination arm will enroll approximately 21 to 30 patients with advanced solid tumors that
are (a) metastatic or unresectable and recurrent, and/or refractory to available therapy, (b)
a condition for which pembrolizumab is an approved treatment, and (c) the patients have shown
either primary or acquired resistance to an ICI. Under protocol amendment 4, DSP-0509 will be
administered on Day 1 and then every 2 weeks thereafter. Pembrolizumab will be initiated on
Day 8 and administered using the dose and schedule described (200 mg IV every 3 weeks).
To maximize patient safety, enrollment in the first combination escalation cohort will begin
at dose level of 0.3 mg DSP-0509 after safety and tolerability of DSP-0509 monotherapy has
been confirmed at least 1 dose level higher.
The primary objective of Combination Therapy Arm C is to determine preliminary efficacy in
the form of the ORR of DSP-0509 when administered in combination with pembrolizumab to an
expansion cohort of patients with HNSCC, using a Bayesian Adaptive design approach.
Combination Arm C will enroll approximately 20 to 40 patients with HNSCC tumors that are (a)
metastatic or unresectable, and recurrent and/or refractory to available therapy, (b) in
patients who have been treated with pembrolizumab or other PD-1 or PD-L1 inhibitors in
monotherapy, and (c) who have subsequently shown either primary or acquired resistance to
Dose escalation of DSP-0509 in combination with 400 mg pembrolizumab q6w will start at the
same dose of DSP-0509 as the highest (not exceeding the MTD) level tested in the combination
regimen with 200 mg pembrolizumab q3w. Upon completion of the DLT evaluation period for the
first DSP-0509 dose level tested in combination with 400 mg pembrolizumab q6w in newly
enrolled patients, if this dose level is found not to exceed the MTD, any ongoing patients
receiving DSP-0509 in combination with pembrolizumab 200 mg q3w will be allowed, at the
investigator's discretion, to transition to the 400 mg pembrolizumab q6w regimen, while
maintaining the originally assigned DSP-0509 dose level.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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