A Phase 1a/1b, multicenter, open-label, non-randomized, dose-escalation, and cohort expansion
study to examine the DLTs, MTD, and RP2D of SB 11285 administered as an IV infusion in
patients with advanced solid tumors.
1. Patient is at least ≥18 years of age (male or female).
2. Disease characteristics for patients in Part 1:
a. Patient with any histologically or cytologically confirmed solid tumor that is
locally advanced or metastatic or unresectable tumor and has disease progression after
treatment with available therapies that are known to confer clinical benefit or who
are intolerant to treatment.
Note: Tumor types of primary interest in Part 1 Dose Escalation include tumors which
are relapsed or refractory after anti PD-1 therapy (include but not limited to
malignant melanoma, HNSCC, renal cell carcinoma, hepatocellular carcinoma, Merkel cell
carcinoma, urothelial, non-small cell lung cancer, gastric carcinoma, ovarian
carcinoma, endometrial, TNBC, cervical cancer, and colorectal carcinoma)
3. Disease characteristics and prior treatments for patients in Part 2:
1. Cohort A (Melanoma): Patients with advanced or metastatic melanoma who have
progressed following treatment with an anti-PD-1 or anti-PD-L1 antibody. Patients
with BRAF mutated melanoma must have previously received BRAF/MEK targeted
2. Cohort B (Head and Neck): Patient has anti-PD-1/PD-L1 refractory metastatic or
recurrent HNSCC of the oral cavity, oropharynx, hypopharynx, or larynx.
Participants may not have a primary tumor site of the nasopharynx (any
i. Has histologically confirmed Stage III, IVa, or IVb disease per TNM staging,
American Joint Committee on Cancer (AJCC, 8th edition), with recurrent or persistent
disease after definitive chemoradiation, deemed unresectable and considered refractory
to both platinum-based combination chemotherapy and anti-PD-1/PD-L1 antibody therapy
OR ii. Has histologically confirmed Stage IVc disease per TNM staging, AJCC 8th
edition, considered refractory to platinum-based combination chemotherapy and
anti-PD-1/PD-L1 antibody therapy.
c. Cohort C: Tumor types not in Cohort A and B - Naïve or relapsed refractory to anti
4. An Eastern Cooperative Oncology Group (ECOG) performance status ≤1
5. Estimated life expectancy ≥3 months
6. Measurable disease according to RECIST criteria v 1.1
7. Patients must have recovered (ie, to NCI CTCAE grade ≤1) from all toxicity associated
with previous treatments (exception: patients may enter with continuing alopecia
irrespective of CTCAE grade).
8. All women of childbearing potential must have a negative pregnancy test at Screening,
prior to study drug administration
9. Women of childbearing potential include any female who has experienced menarche and
who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal
ligation, or bilateral oophorectomy) or is not postmenopausal. Postmenopausal is
defined as: (1) Amenorrhea ≥12 consecutive months without another cause and a
documented serum follicle stimulating hormone (FSH) level >35 mIU/mL; (2) Women with
irregular menstrual periods and a documented serum FSH level >35 mIU/mL; or (3) Women
on hormone replacement therapy (HRT)
10. All patients, male and female, who are not surgically sterilized or postmenopausal as
defined above, must agree to use dual effective birth control during the study and for
at least 28 days after the last dose of study medication.
Highly effective methods of contraception are hormonal contraceptives (oral,
injectable, patch, intrauterine devices), male partner sterilization, or total
abstinence from heterosexual intercourse, when this is the preferred and usual
lifestyle of the patient. Note: The double-barrier method (eg, synthetic condoms,
diaphragm, or cervical cap with spermicidal foam, cream, or gel), periodic abstinence
(such as calendar, symptothermal, post-ovulation), withdrawal (coitus interruptus),
lactational amenorrhea method, and spermicide only are not acceptable as highly
effective methods of contraception
11. Patients has adequate hematologic and organ function, defined as:
1. ANC ≥1500 mm3
2. Platelets ≥100,000/mm3
3. Hemoglobin ≥9 g/dL Note: Patients with Hb 7 to ≤9 g/dL (without bleeding)
transfused prior to dosing in order to meet eligibility criteria
4. Creatinine clearance ≥60 mL/min by Cockcroft-Gault (C-G) equation or estimated
glomerular filtration rate (eGFR) ≥ 60 mL/min
5. Alanine aminotransferase (ALT), aspartate transaminase (AST) ≤3.0× the upper
limit of normal (ULN) if no liver involvement or ≤5×ULN with liver involvement
6. Adequate coagulation: prothrombin time (PT) and an International Normalized Ratio
(INR) and activated partial thromboplastin time (aPTT) ≤1.5×ULN
7. Total bilirubin ≤1.5×ULN (or total serum bilirubin ≤3×ULN for patients with
12. Patients must be willing and able to provide written informed consent prior to the
performance of any study-specific procedure
1. Women who are pregnant or lactating or expecting to conceive a child within the
projected duration of the study
2. History or evidence of cardiovascular (CV) risk including any of the following: Recent
(within the past 6 months) history of serious uncontrolled cardiac arrhythmia or
clinically significant ECG abnormalities including second degree (Type II) or third
degree atrioventricular block; Cardiomyopathy, myocardial infarction, acute coronary
syndromes (including unstable angina pectoris), coronary angioplasty, stenting, or
bypass grafting within the past 6 months before enrolment; Congestive heart failure
(Class II, III, or IV) as defined by the New York Heart Association functional
classification system (NYHA).
3. Patients with marked Baseline QTc prolongation (QT interval corrected for rate by
Fridericia's formula [QTcF] ≤470 msec for women and ≤450 msec for men on the ECG
obtained at Screening by mean of three ECGs).
4. Use of concomitant medications known to prolong QT interval.
5. Patients with active, ongoing infection requiring systemic antibiotic therapy or with
active Epstein-Barr virus, hepatitis B virus, or hepatitis C virus or with known human
immunodeficiency virus (HIV) infection. Note: HIV testing is not required for
eligibility, but if performed previously and was positive, the patient is ineligible
for the study
6. Clinically significant pulmonary disease, chronic or recurrent renal or urinary tract
disease, liver disease, endocrine disorder, autoimmune disorder, or neuromuscular,
musculoskeletal, or mucocutaneous conditions that, in the opinion of the Investigator,
put the patient at additional risk by participating in the study or otherwise make the
patient unsuitable for the study
7. The patient has uncontrolled intercurrent illness including, but not limited to
uncontrolled infection, including uncontrolled diabetes mellitus or decreased
pulmonary function, or psychiatric illness/social situations that would limit
compliance with study
8. Has an active autoimmune disease that has required systemic treatment in the past 2
years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive
drugs) except vitiligo or resolved childhood asthma/atopy. Replacement therapy, such
as thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal
or pituitary insufficiency, is not considered a form of systemic treatment
9. Patients with a history of or active drug induced pneumonitis Grade ≥ 2.
10. Patients who have discontinued prior immunotherapy due to immune-related adverse
11. Is on chronic systemic steroid therapy in excess of replacement doses (prednisone ≤10
mg/day is acceptable), or on any other form of immunosuppressive medication. Note: The
use of physiologic replacement doses of corticosteroids may be approved after
consultation with the Sponsor's Medical Monitor or designee
12. Patients who have undergone major surgery within the last 4 weeks
13. Patients with new brain metastasis. Patients with treated (surgically excised or
irradiated) and stable brain metastases are eligible as long as the treatment was at
least 4 weeks prior to initiation of study drug and baseline brain CT with contrast or
MRI within 2 weeks of initiation of study drug is negative for new brain metastases
14. Active malignant disease other than that being treated in this study. Exceptions:
malignancies that were treated curatively and have not recurred within the past 2
years; completely resected basal cell carcinoma and squamous cell carcinoma of the
skin; and completely resected carcinoma in situ of any type.
15. Patient- Prior treatment with the following agents:
1. Stimulator of Interferon Genes (STING) agonist at any time.
2. Anticancer therapy or investigational therapy within 28 days or 5 half-lives of
the drug, whichever is shorter; "Check-point inhibitors", including Programmed
death receptor-1 (PD-1), PD-L1 and Cytotoxic T-lymphocyte-associated antigen 4
(CTLA-4) inhibitors within 28 days (except part 2 Cohort C);
3. Prior radiation therapy: permissible if at least 1 non-irradiated measurable
lesion is available for assessment according to RECIST version 1.1 or if a
solitary measurable lesion was irradiated, objective progression is documented. A
wash out of at least 28 days before start of study treatment for radiation of any
intended use to the extremities for bone metastases and 28 days for radiation to
the chest, brain, or visceral organs is required. Palliative radiation is
permissible at any time before or during the study.
16. Receipt of any live vaccines within 4 weeks prior to the initiation of study drug.
17. Patients considered by Investigators for any other reason to be unsuitable for the
study or unable to comply with all study procedures and follow-up examinations.