A Phase 2, Open-Label, Multi-cohort Study of PD-L1 Probody* Therapeutic CX-072 in Combination With Other Anticancer Therapy in Adults With Solid Tumors
(PROCLAIM-CX-072-002)

1. At least 18 years of age
2. Measurable disease as defined by RECIST v1.1
3. Eastern Cooperative Oncology Group (ECOG) performance status of *1
4. Agree to provide tumor tissue and blood samples for biomarker assessment
* Part A: Must agree to provide mandatory archival tumor tissue (formalin-fixed
paraffin embedded tumor block or unstained slides) or undergo a new tumor
biopsy
* Part B: Must agree to provide tumor tissue from the initial diagnostic biopsy
and prospectively agree to provide tumor tissue obtained from surgery on study
for pathologic analysis and for biomarker assessment
5. Subjects with treated brain metastases are eligible if the brain metastases
are stable (no magnetic resonance imaging [MRI] evidence of progression for at
least 8 weeks after treatment is complete and within 28 days prior to first
dose of study treatment) and the subject does not require radiation therapy or
steroids. Active screening for brain metastases (eg, brain computed tomography
[CT] or MRI) is not required
6. Screening laboratory values must meet all of the following criteria:
* White blood cells >2000/µL or 2.0 × 10 to the power of 9/L
* Neutrophils *1500/µL or 1.5 × 10 to the power of 9/L
* Platelets *100 × 10 to the power of 3/µL or 100 × 10 to the power of 9/L
* Hemoglobin *9.0 g/dL (may have been transfused) or 90.0 g/L
* Creatinine *2 mg/dL or 176.8 µmol/L OR measured or calculated creatinine
clearance (glomerular filtration rate can also be used in place of creatinine
or creatinine clearance) >50 mL/min
* AST and ALT *2.5 × upper limit of normal (ULN)
* Total bilirubin within ULN (unless diagnosed with Gilbert*s syndrome, those
subjects must have a total bilirubin <3.0 mg/dL or 51.3 µmol/L)
* Amylase and lipase *1.5 × ULN
* International normalized ratio (INR) and activated partial thromboplastin
time (aPTT) *1.5 × ULN (unless subject is on therapeutic anticoagulation, at
which time the INR and aPTT must be in the target therapeutic anticoagulation
range)
* Serum albumin *2.5 g/dL
7. Females of childbearing potential and nonsterile males must agree to
practice highly effective methods of birth control (as described in Appendix C)
for the duration of the study and for 6 months after the last dose of study
treatment
8. The ability to understand and the willingness to sign a written ICF and
adhere to study schedule and prohibitions
See additional cohort-specific inclusion criteria in Sections 4.2, 4.3, 4.4,
and 4.5 of the Protocol.

1. Treatment with cytotoxic chemotherapy, biologic agents, radiation,
immunotherapy, or any investigational agent within 28 days prior to the first
dose of study treatment. This interval can be reduced to 2 weeks for subjects
who received bone-only radiation therapy or for subjects whose most recent
prior therapy was a single-agent, small-molecule kinase inhibitor having a
half-life of 3 days or less.
- For Cohort A2: Prior anti-PD-1/PD-L1 antibody given as a single agent is not
excluded within the 28 days prior to the first dose of study treatment. Time
from last dose of prior anti-PD-1/PD-L1 inhibitor to first dose of study
treatment must be at least the same length as the time interval of the prior
PD-1/PD-L1 dosing schedule (eg, if prior PD-1/PD-L1 dosing was once every 14
days, then the last dose must have been at least 14 days prior to first dose
of study treatment)
2. Prior therapy with a chimeric antigen receptor T cell*containing regimen
3. History of active autoimmune disease(s) including but not limited to
inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis,
autoimmune hepatitis, systemic sclerosis, systemic lupus erythematosus,
autoimmune vasculitis, autoimmune neuropathies, type 1 insulin-dependent
diabetes mellitus
4. History of myocarditis regardless of the cause
5. History of intolerance to prior checkpoint inhibitor therapy defined as the
need to discontinue treatment due to an irAE
6. History of toxic epidermal necrolysis or Stevens-Johnson syndrome
7. History of any syndrome or medical condition that required treatment with
systemic steroids (*10 mg daily prednisone equivalents) or immunosuppressive
medications. However, subjects who required brief courses of steroids (eg, as
prophylaxis for IV contrastor for treatment of an allergic reaction) may be
eligible with Sponsor approval. Inhaled or topical steroids are permitted.
8. Baseline corrected QT interval (QTc) >470 ms. If a subject starts on a
QTc prolonging drug(s), a series of electrocardiograms (ECGs) should be
obtained to redefine the baseline QTc.
9. Unresolved acute toxicity CTCAE v5.0 Grade *1 (or baseline, whichever is
greater) from prior anticancer therapy. Alopecia and other nonacute toxicities
are acceptable. Hormone deficiency due to prior anticancer therapy that is
deemed stable with supplementation or does not require supplementation is
allowed.
10. History of severe allergic or anaphylactic reactions to human mAb therapy
or known hypersensitivity to any Probody therapeutic
11. Subjects with known human immunodeficiency virus, acquired immune
deficiency syndrome, or any related illness
12. Subjects with acute or chronic hepatitis B or C
13. History of allogeneic tissue/solid organ transplant, stem cell transplant,
or bone marrow transplant
14. Major surgery (eg, that required general anesthesia) within 4 weeks prior
to the first dose of study treatment (and must be confirmed to be completely
healed), or minor surgery (eg, not
involving chest, abdomen, or intracranial structures) or gamma knife treatment
(with adequate healing) within 14 days prior to first dose of study treatment
(excluding biopsies conducted with local/topical anesthesia) if complete
healing is confirmed
15. History of active malignancy not related to the cancer being treated within
the previous 2 years, with the exception of localized cancers that are
considered cured and, in the opinion of the Investigator, present a low risk
for recurrence. These exceptions include, but are not limited to, basal or
squamous cell skin cancer, superficial bladder cancer, and carcinoma in situ of
the prostate, cervix, or breast.
16. Received a live vaccine within 30 days prior to the first dose of study
treatment. Examples of live vaccines include, but are not limited to, the
following: measles, mumps, rubella, chicken pox/zoster, yellow fever, rabies,
Bacillus Calmette-Guérin, and typhoid vaccine.
17. Intercurrent illness including, but not limited to:
* Ongoing severe aortic stenosis
* Myocardial infarction or stroke within 24 weeks prior to first dose of study
treatment
* Any of the following within 12 weeks prior to first dose of study treatment:
symptomatic congestive heart failure (ie, New York Heart Association Class III
or IV), unstable angina pectoris, or clinically significant and uncontrolled
cardiac arrhythmia
* Nonhealing wound or ulcer within 4 weeks prior to Cycle 1 Day 1
* Active infection requiring systemic antiviral, antibiotic, or antifungal
therapy within 5 days prior to first dose of study treatment
18. Pleural or pericardial effusion or ascites requiring drainage *1 time(s)
per month
19. History of multiple myeloma
20. Women who are pregnant or breastfeeding

See additional cohort-specific exclusion criteria in Sections 4.7 and 4.8 of
the Protocol.