A Phase 1 Dose Escalation and Expanded Cohort Study of PF-06821497 in the Treatment of Adult Patients with Relapsed/Refractory Small Cell Lung Cancer (SCLC), Castration Resistant Prostate Cancer (CRPC) and Follicular Lymphoma (FL)

A Phase 1 Dose Escalation and Expanded Cohort Study Of PF-06821497 In The Treatment Of Adult
Patients With Relapsed/Refractory Small Cell Lung Cancer (SCLC), Castration Resistant
Prostate Cancer (CRPC) And Follicular Lymphoma (FL).

Key Inclusion Criteria:

Histological or cytological diagnosis of advanced / metastatic solid tumor with the
following tumor types in individual study parts:

Part 1A (closed to enrollment):

Part 1B (closed to enrollment):

Part 1C:

- Castration resistant prostate cancer. Patients should have received either abiraterone
and/or enzalutamide treatment and have evidence of prostate cancer progression (per
PCWG3) Japan cohort

- Castration resistant prostate cancer that is resistant to SOC or for which no local
regulatory approved SOC is available that would confer significant clinical benefit in
the medical judgement of the investigator. Patients should have received either
abiraterone and/or enzalutamide treatment and have evidence of prostate cancer
progression (per PCWG3) China cohort

- Castration resistant prostate cancer that is intolerant/resistant to SOC or for which
no local regulatory approved SOC is available that would confer significant clinical
benefit in the medical judgement of the investigator. Patients who refused SOC may be
eligible. Patients should have received either abiraterone and/or enzalutamide
treatment and have evidence of prostate cancer progression (per PCWG3)

Part 2A:

• Castration resistant prostate cancer. Patients should have received either abiraterone
and/or enzalutamide treatment, may have received up to 1 line of chemotherapy and have
evidence of prostate cancer progression (per PCWG3)

Part 2B:

- Castration resistant prostate cancer. Patients should have received abiraterone
treatment, may have received up to 1 prior line of chemotherapy, have not received
prior enzalutamide, apalutamide or darolutamide and have evidence of prostate cancer
progression (per PCWG3)

- Patients must have radiographic evidence of disease

Other inclusion criteria:

- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.

- Adequate organ function

Key Exclusion Criteria:

- Prior Chemotherapy: Part 1C , Japan cohort and China cohort (CRPC): no more than 2
previous regimens of chemotherapy Part 2A: CRPC: no more than 1 previous regimen of
systemic chemotherapy Part 2B (CRPC): no more than 1 previous regimen of chemotherapy

- Prior irradiation to >25% of the bone marrow.

- QTcF interval >480 msec at screening.

- Hypertension that cannot be controlled by medications (>150/90 mmHg despite optimal
medical therapy).

- Known or suspected hypersensitivity to PF 06821497 or any components or enzalutamide
(CRPC)

- Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular
disease or previous gastric resection or lap band surgery. Gastroesophageal reflux
disease under treatment with proton pump inhibitors is allowed.

- Current use or anticipated need for food or drugs that are known strong CYP3A4/5
inducers or inhibitors, including their administration within 10 days or 5 half lives
of the CYP3A4/5 inhibitor, whichever is longer prior to first dose of investigational
product.