EndoMAP: A Phase IB/II Multi-Cohort Study of Targeted Agents and/or Immunotherapy with Atezolizumab for Patients with Recurrent or Persistent Endometrial Cancer

This is a Phase IB/II multi-cohort study designed to evaluate the efficacy and safety of
targeted agents with or without cancer immune checkpoint therapy with atezolizumab in
participant with recurrent and/or persistent endometrial cancer. The main protocol
provides a platform for genomic screening with homogeneous basic eligibility criteria in
order to direct study participants into biomarker-matched study cohorts consisting of
testing targeted agents.

Key Inclusion Criteria:

- Recurrent or persistent endometrial carcinoma which has progressed or recurred after
at least 1, but no more than 2, prior lines of therapy. Prior hormonal therapies
(e.g., tamoxifen, aromatase inhibitors) will not count toward the prior regimen
limit. Chemotherapy given in conjunction with radiotherapy as a radiosensitizer will
be counted as a systemic therapeutic regimen.

- Measurable disease per RECIST 1.1

- Availability of a representative tumor specimen that is suitable for determination
of biomarker status via central testing (F1CDx) OR If a patient has a prior F1CDx
report from 1 September 2019 or later, those NGS results can be used to determine
biomarker status as long as the tumor tissue used in the report was obtained within
5 years prior to prescreening and appropriate signed consent is obtained from the
patient.

- Life expectancy > 12 weeks

- Recovery from effects of recent radiotherapy, surgery, or chemotherapy

Key Exclusion Criteria:

- Endometrial tumors with the following histologies: squamous carcinomas, sarcomas

- Other invasive malignancies within the last 5 years, except for non-melanoma skin
cancer with no evidence of disease within the past 5 years AND localized breast
cancer with previous adjuvant chemotherapy treatment for breast cancer completed > 5
years ago

- Synchronous primary invasive ovarian or cervical cancer

- Have an active or history of autoimmune disease or immune deficiency

- Have a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis based on a
screening chest computed tomography (CT) scan

- Active tuberculosis

- Severe infections within 4 weeks

- Have received therapeutic oral or IV antibiotic medication within 2 weeks, except
prophylactic antibiotic medication

- Have significant cardiovascular disease

- Are administered treatment with a live attenuated vaccine within 4 weeks, or
anticipation of need for such a vaccine during the course of the study

- Have prior allogeneic bone marrow transplantation or solid organ transplant

- History of treatment with systemic immunostimulatory agents (including but not
limited to interferons, interleukin-2) within 4 weeks or 5 half-lives of the drug,
whichever is longer, prior to initiation of study treatment

- History of treatment with systemic immunosuppressive medications within 2 weeks
except acute, low-dose, systemic immunosuppressant medications, corticosteroids for
chronic obstructive pulmonary disease and asthma, or mineralocorticoids and low-dose
corticosteroids for participants with orthostatic hypotension or adrenocortical
insufficiency

- Have a history or clinical evidence of any untreated CNS disease, seizures not
controlled with standard medical therapy, or history of cerebrovascular accident
(stroke), transient ischemic attack or subarachnoid hemorrhage within 6 months

AFT-50A Specific Exclusion Criteria:

● Prior treatment with T-cell costimulating or immune checkpoint blockade therapies
including, but not limited to, CD137 agonists, anti-PD-1, anti-PD-L1, and anti-CTLA-4
therapeutic antibodies

Note: Additional study cohort specific inclusion and exclusion criteria may apply based
on cohort assignment.