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MelanomaPhase 1NCT04096638

Safety and Efficacy of SB 11285 Alone and in Combination With Atezolizumab in Patients With Advanced Solid Tumors

A Phase 1 study testing SB 11285 and Atezolizumab in people with Melanoma and Head and Neck Squamous Cell Carcinoma, run by invoX Pharma Limited at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SB 11285 and Atezolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
2 sitesUnited States
Study dates
23 Sep 2019to 16 Jul 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient is at least ≥18 years of age (male or female).
  • Disease characteristics for patients in Part 1:
  • 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/PD-L1 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)
  • Disease characteristics and prior treatments for patients in Part 2:
  • 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 therapy.
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  • 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 histology).
  • 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.
  • Cohort C: Tumor types not in Cohort A and B - Naïve or relapsed refractory to anti PD-1/PD-L1
  • An Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  • Estimated life expectancy ≥3 months
  • Measurable disease according to RECIST criteria v 1.1
  • 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).
  • All women of childbearing potential must have a negative pregnancy test at Screening, prior to study drug administration
  • 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)
  • 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 and 5 months after the last dose of atezolizumab.
  • 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
  • Patients has adequate hematologic and organ function, defined as:
  • ANC ≥1500 mm3 without requiring G-CSF
  • Platelets ≥100,000/mm3
  • 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
  • Serum creatinine ≤1.5× upper limit of normal (ULN) for the reference laboratory or creatinine clearance ≥50 mL/min within the 28 days before enrollment (calculated from Cockcroft-Gault formula or 24 hour urine collection).
  • Alanine aminotransferase (ALT), aspartate transaminase (AST) ≤3.0× the upper limit of normal (ULN) if no liver involvement or ≤5×ULN with liver involvement
  • Adequate coagulation: prothrombin time (PT), an International Normalized Ratio (INR) or activated partial thromboplastin time (aPTT) ≤1.5×ULN or for patients requiring anticoagulant therapy, the PT/INR, aPTT should be within therapeutic range of the given anticoagulant agent
  • Total bilirubin ≤1.5×ULN (or total serum bilirubin ≤3×ULN for patients with Gilbert's disease)
  • Patients must be willing and able to provide written informed consent prior to the performance of any study-specific procedure

Who cannot join

  • Women who are pregnant or lactating or expecting to conceive a child within the projected duration of the study
  • 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).
  • 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).
  • Use of concomitant medications known to moderately or severly prolong QT interval.
  • Patients with active or ongoing infection requiring systemic IV antibiotic therapy. Patients with active or ongoing Epstein-Barr virus, hepatitis B virus, or hepatitis C virus or with known human immunodeficiency virus (HIV) infection, tuberculosis, or other infections within 4 weeks.
  • 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
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  • 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
  • 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
  • Patients with a history of or active pneumonitis Grade ≥ 2 (from any etiology).
  • Patients who have discontinued prior immunotherapy due to immune-related adverse reaction(s)
  • 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
  • Patients who have undergone major surgery within the last 4 weeks
  • 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
  • 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.
  • Patient- Prior treatment with the following agents:
  • Stimulator of Interferon Genes (STING) agonist at any time.
  • 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);
  • 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.
  • Receipt of any live vaccines within 4 weeks prior to the initiation of study drug and anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab.
  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

Other trials in United States

About this study

Official title: A Phase 1a/1b Dose-escalation Study of Intravenously Administered SB 11285 Alone and in Combination With Atezolizumab in Patients With Advanced Solid Tumors

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.

Read the detailed description

Part 1a of the study will assess the safety and tolerability of SB 11285 as monotherapy in eligible patients with advanced solid tumors. Part 1b will assess the safety and tolerability of SB 11285 in combination with atezolizumab in patients with advanced solid tumors. RP2D decisions will be based on the totality of data, including DLTs, tolerability, PK, pharmacodynamics, and efficacy, as available. Part 2 will further evaluate the combination RP2D of SB 11285 and atezolizumab in selected tumor types. Both Parts 1a and 1b of the study will use a standard 3+3 dose-escalation design with the dose escalated in successive cohorts of 3 to 6 patients each within each cohort in an open-label fashion. In Part 1a Monotherapy Dose Escalation, patients who meet eligibility criteria will receive IV SB 11285 as monotherapy weekly on Days 1, 8, 15, and 22 of repeated 28-day cycles in escalating doses. Once Dose Level 2 of Part 1a monotherapy have been evaluated by the Safety Review Committee (SRC) and have been declared to be safe to dose escalate to Dose Level 3, Dose Level 1 of Part 1b Combination Dose Escalation (SB 11285 combination with atezolizumab) will be opened for enrollment. After determination of MTD and RP2D in SB 11285 plus atezolizumab combination the Part 2 with Expansion Cohorts will commence to further evaluate the RP2D.

Being tested
SB 11285, Atezolizumab
Medical subject headings
Melanoma, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SB 11285Drug

    SB 11285 2mg lyophilized powder for IV infusion

  • AtezolizumabDrug

    Also called Tecentriq

    1680 mg every 4 weeks

Study groups in NCT04096638
Study groupRoleWhat they receive
Part 1a: Monotherapy Dose EscalationExperimentalSB 11285 weekly on Days 1, 8, 15 and 22 on repeated 28-day cycles in escalating doses
Receives: Drug: SB 11285
Part 1b: PD-L1 Combination Dose EscalationExperimentalSB 11285 weekly on Days 1, 8, 15 and 22 on repeated 28-day cycles in escalating doses plus 1680mg every 4 weeks (Q4W) atezolizumab
Receives: Drug: SB 11285; Drug: Atezolizumab
Part 2: Combination Expansion Cohorts at RP2D (Cohort A)ExperimentalCohort A: Patients with Melanoma After determination of maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) in SB 11285 plus atezolizumab combination the Part 2 with expansion cohorts will commence to further evaluate the RP2D.
Receives: Drug: SB 11285; Drug: Atezolizumab
Part 2: Combination Expansion Cohorts at RP2D (Cohort B)ExperimentalCohort B: Patients with HNSCC After determination of maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) in SB 11285 plus atezolizumab combination the Part 2 with expansion cohorts will commence to further evaluate the RP2D.
Receives: Drug: SB 11285; Drug: Atezolizumab
Part 2: Combination Expansion Cohorts at RP2D (Cohort C)ExperimentalCohort C: Patients with tumor types other then Cohort A and B (Naïve or relapsed refractory to anti PD-1/PD-L1) After determination of maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) in SB 11285 plus atezolizumab combination the Part 2 with expansion cohorts will commence to further evaluate the RP2D.
Receives: Drug: SB 11285; Drug: Atezolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Observation of DLT

    Dose-limiting toxicity (DLT) is defined as a clinically significant adverse event or abnormal laboratory value occurring during Cycle 1 (Days 1-28) during both monotherapy and Combination dose-escalation portions of Part 1. Adverse events will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

    Measured: Cycle 1 (4 weeks)

  2. Part 1: Determination of the MTD

    The maximum tolerated dose (MTD) will be defined as the highest dose level below the maximum administered dose that has confirmed less than 2 out of 6 subjects with DLT. At least 6 subjects evaluable for the safety endpoint must be entered at this dose level before it may be confirmed as the MTD.

    Measured: Cycle 1 (4 Weeks)

  3. Part 1: Determination of the RP2D

    The recommended phase 2 dose (RP2D) will be based on a consideration of the totality of data including but not limited to safety data (including DLTs), PK, PD and preliminary efficacy, as available after completion of Part 1

    Measured: 8 weeks to 12 months

  4. Part 1: Incidence of Adverse Events [Safety and Tolerability]

    Incidence of adverse events of SB 11285 as a monotherapy and in combination with atezolizumab when administered as an IV infusion, as determined by patient reporting, clinical laboratory test changes from baseline (hematology, serum chemistry, coagulation, urinalysis, pregnancy, thyroid panel), and clinically significant changes in physical examination data (vital signs and ECG)

    Measured: 4 weeks to 12 months

  5. Part 2: Preliminary antitumor activity of SB 11285 in combination with atezolizumab

    Preliminary antitumor activity of SB 11285 in combination with atezolizumab in patients with solid tumors, will be evaluated in terms of objective response rate as assessed by the Investigators using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and and by iRECIST

    Measured: 28 Days to 12 months

  6. Part 2: Confirmation of recommended RP2D and schedule of SB 11285 in combination with atezolizumab

    Confirmation of the recommended phase 2 dosage (RP2D) and dosing interval will be based on consideration of the totality of available data, including safety, PK, PD, and preliminary efficacy, as available.

    Measured: 4 weeks to 12 months

  7. Part 2: Incidence of adverse events [Safety and Tolerability]

    Incidence of adverse events of SB 11285 in combination with atezolizumab when administered as an IV infusion, as determined by patient reporting, clinical laboratory test changes from base line (hematology, serum chemistry, coagulation, urinalysis, pregnancy, thyroid panel), and clinically significant changes in physical examination data (vital signs and ECG)

    Measured: 4 Weeks to 12 months

Secondary outcomes (11)

  1. Part 1 and 2: Cmax (Plasma of SB 11285)

    To characterize the plasma pharmacokinetics (PK) of SB 11285 following IV administration of SB 11285 as monotherapy and in combination with atezolizumab, the PK endpoint maximum plasma concentration (Cmax) will be measured.

    Measured: up to 12 months

  2. Part 1 and 2: Time to Cmax (Plasma of SB 11285 )

    To characterize the plasma pharmacokinetics (PK) of SB 11285 following IV administration of SB 11285 as monotherapy and in combination with atezolizumab, the PK endpoints time to maximum plasma concentration (Cmax) will be measured.

    Measured: up to 12 months

  3. Part 1 and 2: AUC (Plasma of SB 11285 )

    To characterize the plasma pharmacokinetics (PK) of SB 11285 following IV administration of SB 11285 as monotherapy and in combination with atezolizumab, the PK endpoint area under the concentration-time curve will be measured.

    Measured: up to 12 months

  4. Part 1 and 2: Cmax (Plasma of SB 11312)

    To characterize the plasma pharmacokinetics (PK) of SB 11312 following IV administration of SB 11285 as monotherapy and in combination with atezolizumab, the PK endpoint maximum plasma concentration (Cmax) will be measured.

    Measured: up to 12 months

  5. Part 1 and 2: Time to Cmax (Plasma of SB 11312)

    To characterize the plasma pharmacokinetics (PK) of SB 11312 following IV administration of SB 11285 as monotherapy and in combination with atezolizumab, the PK endpoints time to maximum plasma concentration (Cmax) will be measured.

    Measured: up to 12 months

  6. Part 1 and 2: AUC (Plasma of SB 11312)

    To characterize the plasma pharmacokinetics (PK) of SB 11312 following IV administration of SB 11285 as monotherapy and in combination with atezolizumab, the PK endpoint area under the concentration-time curve will be measured.

    Measured: up to 12 months

  7. Part 1 and 2: Plasma of SB 11312

    To characterize the plasma pharmacokinetics (PK) of SB 11312 following IV administration of SB 11285 as monotherapy and in combination with atezolizumab, the PK endpoint area under the concentration-time curve will be measured.

    Measured: up to 12 months

  8. Part 1: Objective response rate (ORR)

    Objective response rate (ORR) assessed by RECIST v 1.1 for patients in Part 1 only

    Measured: 4 weeks to 12 months

  9. Part 1 and 2: Duration of response (DOR)

    Duration of response (DOR) assessed by RECIST v 1.1 and by iRECIST (Part 1 and 2)

    Measured: 4 weeks to 12 months

  10. Part 1 and 2: Progression-free survival (PFS)

    Progression-free survival (PFS) assessed by RECIST v 1.1 and by iRECIST

    Measured: 4 weeks to 12 months

  11. Part 1 and 2: Overall survival (OS)

    Overall survival (OS) is defined as time from date of first study treatment to death due to any cause. The Kaplan-Meier method will be used to estimate the median OS.

    Measured: up to 39 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2019
  2. Study start23 Sep 2019
  3. Primary completion16 Jul 2024
  4. Study completion16 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04096638
Sponsor's protocol ID
SBP-11285-ONC-101
Status last verified
Mar 2024
First submitted
3 Sep 2019
Last updated
31 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SB 11285 and Atezolizumab in people with Melanoma and Head and Neck Squamous Cell Carcinoma, run by invoX Pharma Limited at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Observation of DLT (time frame: Cycle 1 (4 weeks)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04096638.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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