Squamous Cell Carcinoma of the Head and NeckPhase 1NCT03894618
SL-279252 (PD1-Fc-OX40L) in Subjects With Advanced Solid Tumors or Lymphomas
A Phase 1 study testing SL-279252 in people with Squamous Cell Carcinoma of the Head and Neck and Melanoma, run by Shattuck Labs, Inc. at 5 sites in 4 countries.
Trial summary
This is a Phase 1 first in human, open label, multi-center, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, anti-tumor activity and pharmacodynamic effects of SL-279252 in subjects with advanced solid tumors or lymphomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Head and Neck, Melanoma, Non Small Cell Lung Cancer
- What is being tested?
- SL-279252
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 26 Mar 2019to 4 May 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participants are eligible to be included in the study only if all the following criteria apply.
- Subject has voluntarily agreed to participate by giving written informed consent in accordance with ICH/GCP guidelines and applicable local regulations.
- Subject has a histologically confirmed diagnosis of one of the following unresectable locally advanced or metastatic malignancies: melanoma, non-small cell lung cancer (squamous, adeno, or adeno-squamous), urothelial cancer, squamous cell carcinoma of the head and neck, squamous cell cervical cancer, gastric or gastro-esophageal junction adenocarcinoma, squamous cell carcinoma of the anal canal, squamous cell carcinoma of the skin, renal cell cancer, Hodgkin's lymphoma, and microsatellite instability high (MSI-H) or mismatch repair deficient (MMRD) solid tumors excluding CNS malignancies. MSI and MMRD testing results as per institution is acceptable.
- Head and neck cancers: Subjects must have primary tumor locations in the oropharynx, oral cavity, hypopharynx, or larynx. Primary tumor sites of nasopharynx, maxillary sinus, paranasal, and unknown primary are excluded.
- Non-small cell lung cancers: Subjects with a known EGFR sensitizing (activating) mutation or an ALK fusion are excluded.
- Subject must have received, been intolerant to, or is ineligible for standard therapy (per local guidelines and approvals) or have a malignancy for which there is no approved therapy considered standard of care.
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- Age 18 years and older.
- Has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Has measurable disease by iRECIST (solid tumors) or RECIL 2017 (lymphoma). Refer to Appendix Sections 16.6 and 16.7 for details on criteria of measurable disease.
- Has life expectancy of greater than 12 weeks.
- Laboratory values must meet the following criteria. Laboratory parameter Threshold value
- Absolute lymphocyte count (ALC) ≥ 0.8 x 109/liter (L)
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L without growth factor support
- Platelet count ≥ 50 x 109/L
- Laboratory parameter Threshold value
- Hemoglobin (Hgb) > 9.0 g/dL with no blood transfusions for at least 5 days prior to D1 of investigational product (IP; SL-279252)
- Creatinine clearance (CrCl) ≥ 30 milliliter (mL)/min (modified Cockcroft-Gault)
- ALT/AST ≤ 3 x ULN
- Total bilirubin ≤ 1.5 x ULN; subjects with isolated indirect hyperbilirubinemia are permitted if direct bilirubin ratio is <35% and total bilirubin is ≤ 3.0 x ULN
- Left ventricular ejection fraction (LVEF) by echocardiogram (ECHO) ≥ lower limit of normal (LLN) per institutional threshold. If LLN is not defined for a given institution, then ejection fraction must be ≥50 %.
- Females of child bearing potential (FCBP) must have a negative serum or urine pregnancy test within 72 hours of D1 of IP. NOTE: FCBP unless they are surgically sterile (i.e., have undergone a complete hysterectomy, bilateral tubal ligation/occlusion, bilateral oophorectomy or bilateral salpingectomy), have a congenital or acquired condition that prevents childbearing or are naturally postmenopausal for at least 12 consecutive months (see Appendix Section 16.2 for additional details). Documentation of postmenopausal status must be provided. FCBP should use an acceptable method of contraception (see Appendix Section 16.2) to avoid pregnancy during treatment and for 30 days (which exceeds 5 half-lives) after the last dose of IP. FCBP must start using acceptable contraception at least 14 days prior to D1 of IP.
- Male subjects with female partners must have azoospermia from a prior vasectomy or underlying medical condition or agree to use an acceptable method of contraception during treatment and for 30 days (which exceeds 5 half-lives) after last dose of SL-279252 (see Appendix Section 16.2). Male subjects of reproductive potential must start using acceptable contraception at least 14 days prior to D1 of treatment with SL-279252 as per Appendix Section 16.2.
- All AEs resulting from prior anti-cancer immunotherapy have resolved (NOTE: exceptions include alopecia, vitiligo, and endocrinopathies adequately treated with hormone replacement).
- Subjects that were discontinued from prior PD-1/L1 therapy due to immune-related adverse events are not eligible
- Recovery from toxicities from prior anti-cancer treatments including surgery, radiotherapy, chemotherapy or any other anti-cancer therapy to baseline or ≤ Grade 1. (NOTE: Low-grade toxicities (e.g., alopecia, ≤ Grade 2 lymphopenia, ≤ Grade 2 hypomagnesemia, ≤ Grade 2 neuropathy) may be allowed at the discretion of the investigator if considered clinically insignificant. Please consult the Sponsor Medical Monitor to discuss these cases).
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- Has received more than two prior checkpoint inhibitor containing treatment regimens (regimen refers to either monotherapy or combination immunotherapies) or has had prior treatment with an OX40 agonist.
- Prior PD-1/L1 therapy is not required.
- Refractory to last PD-1/L1 inhibitor-based therapy which is defined as disease progression within 3 months of treatment initiation.
- Subjects must have had clinical benefit (stable disease or response) to last PD-1/L1 inhibitor-based therapy for at least three months to be eligible.
- Any anti-cancer therapy within the time intervals noted below prior to first dose (D1) of SL-279252.
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- Therapy Washout period Chemotherapy 3 weeks Hormonal therapy 3 weeks PD-1/L1 inhibitor and other immunotherapies not otherwise specified 3 weeks Tumor vaccine 4 weeks Cell-based therapy 8 weeks Other mAbs or biologic therapies 3 weeks Major surgery 2 weeks Radiation (except palliative intent which does not require washout) 2 weeks
- Concurrent chemotherapy, immunotherapy, biologic or hormonal therapy is prohibited. Concurrent use of hormones for non-cancer related conditions is acceptable.
- Use of corticosteroids or other immunosuppressive medication, current or within 14 days of D1 of IP with the following exceptions (i.e., the following are allowed during treatment with or within14 days of D1 of IP):
- Topical, intranasal, inhaled, ocular, intraarticular corticosteroids
- Physiological doses of replacement steroid (e.g., for adrenal insufficiency) provided ≤ 10 mg/day of prednisone or equivalent
- Steroid premedication for hypersensitivity reactions (HSRs; e.g., reaction to IV contrast)
- Receipt of live attenuated vaccine within 28 days of D1 of IP.
- Active or documented history of autoimmune disease (autoimmune disease does not refer to irAEs; for irAEs see inclusion criteria #11). Exceptions include Type I diabetes, vitiligo, alopecia areata or hypo/hyperthyroidism.
- Active pneumonitis (i.e. drug-induced, idiopathic pulmonary fibrosis, radiation-induced, etc.).
- Ongoing or active infection (e.g., no systemic antimicrobial therapy for treatment of infection within 5 days of D1 of IP).
- Symptomatic peptic ulcer disease or gastritis, active diverticulitis, other serious gastrointestinal (GI) disease associated with diarrhea within 6 months of D1 of IP.
- Clinically significant or uncontrolled cardiac disease including any of the following:
- Myocarditis
- Unstable angina within 6 months from D1 of IP
- Acute myocardial infarction within 6 months from D1 of IP
- Uncontrolled hypertension
- New York Heart Association (NYHA) Class II, III or IV congestive heart failure
- Clinically significant (symptomatic) cardiac arrhythmias (e.g., sustained ventricular tachycardia, second- or third- degree atrioventricular block without a pacemaker, circulatory collapse requiring vasopressor or inotropic support, or arrhythmia requiring therapy)
- Untreated central nervous system (CNS) or leptomeningeal metastases. Subjects with treated CNS metastases must have completed definitive treatment (radiotherapy and/or surgery) > 2 weeks prior to D1 of IP and no longer require steroids.
- Women who are breast feeding.
- Psychiatric illness/social circumstances that would limit compliance with study requirements and substantially increase the risk of AEs or compromised ability to provide written informed consent.
- Another malignancy that requires active therapy and that in the opinion of the investigator and Sponsor would interfere with monitoring of radiologic assessments of response to IP.
- Has undergone allogeneic stem cell transplantation or organ transplantation.
- Known history or positive test for human immunodeficiency virus, or positive test for hepatitis B (positive for hepatitis B surface antigen [HBsAg]) or hepatitis C virus ([HCV]; if HCV antibody (Ab) test is positive check for HCV ribonucleic acid [RNA]).
- (NOTE: Hepatitis B virus (HBV): Subjects who are hepatitis B core antibody [HBcAb] positive, but HBsAg negative are eligible for enrollment. HCV: Subjects who are HCV Ab positive, but HCV RNA negative are eligible for enrollment).
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
United States2 sites
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
The Sarah Cannon Research Institute
Nashville, Tennessee, 37203
About this study
Official title: Phase 1 Dose Escalation and Dose Expansion Study of an Agonist Redirected Checkpoint Fusion Protein, SL-279252 (PD1-Fc-OX40L), in Subjects With Advanced Solid Tumors or Lymphomas
This is a Phase 1 first in human, open label, multi-center, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, anti-tumor activity and pharmacodynamic effects of SL-279252 in subjects with advanced solid tumors or lymphomas.
Read the detailed description
This is a Phase 1 first in human, open label, multi-center, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, anti-tumor activity and pharmacodynamic effects of SL-279252 in subjects with advanced solid tumors or lymphomas. The study design consists of Dose Escalation and Dose Expansion Cohorts. In the dose escalation phase of the study, subjects will be enrolled into sequential dose levels. During dose escalation, two possible schedules for administration of SL-279252 may be explored. The MTD or MAD may be determined for either schedule. Based on accumulating data from the dose escalation phase, including safety, PK, pharmacodynamic and anti-tumor activity, up to two dose expansion cohorts may be opened. The primary objective of the expansion phase is to further refine the safety and tolerability of SL-279252. The expansion cohorts will evaluate one or two doses of SL-279252 using one selected schedule. At the end of dose escalation and dose expansion, safety, PK, anti-tumor activity, and pharmacodynamic data will be reviewed to identify the RP2D.
- Conditions
- Squamous Cell Carcinoma of the Head and Neck, Melanoma, Non Small Cell Lung Cancer, Urothelial Carcinoma, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
- Being tested
- SL-279252
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Melanoma, Carcinoma, Non-Small-Cell Lung, Carcinoma, Transitional Cell, Anus Neoplasms, Carcinoma, Renal Cell, Hodgkin Disease, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SL-279252Drug
The investigational product (IP), SL-279252, is a first-in-class agonist redirected checkpoint (ARC) fusion protein (FP) consisting of the extracellular domains of human programmed cell death 1 (PD- 1) and OX40L, linked by a central Fc domain (PD1-Fc-OX40L).
| Study group | Role | What they receive |
|---|---|---|
| SL-279252 | Experimental | Intravenous administration; Two possible dosing schedules for SL-279252 may be evaluated Receives: Drug: SL-279252 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Profile of SL-279252
Number of participants with treatment emergent adverse events
Measured: From Day 1 to 90 days after Last Dose of SL-279252
Maximum Tolerated Dose (MTD) of SL-279252
Number of participants with dose limiting toxicities (DLTs)
Measured: From Day 1 to Day 21 (Schedule 1) or Day 28 (Schedule 2)
Secondary outcomes (10)
Recommended Phase 2 Dose for SL-279252
Based on review of all data, including safety, tolerability, PK, antitumor activity, and PD effects
Measured: Approximately 32 months
Overall Response Rate of SL-279252
Objective response rate per immune response evaluation criteria in solid tumors (iRECIST) for solid tumors
Measured: Approximately 32 months
Immunogenicity to SL-279252
Number of participants with positive anti-drug antibody (ADA) titer, of those who were ADA negative at baseline
Measured: Approximately 32 months
Maximum Serum Concentration (Cmax) of SL-279252
The Cmax is the maximum observed serum concentration of SL-279252 following single and multiple doses
Measured: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (cycle = 28 days)
Minimum Serum Concentration (Cmin) of SL-279252
The Cmin is the minimum observed serum concentration of SL-279252 following single and multiple doses
Measured: Cycle 1 Day 15 and Cycle 2 Day 1 (cycle = 28 days)
Time at Which Maximum Concentration of SL-279252 is Observed (Tmax)
The Tmax is the time at which the maximum concentration of SL-279252 is observed following single and multiple doses
Measured: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (cycle = 28 days)
Area Under the Serum Concentration-time Curve (AUC)
The AUC is the area under the serum concentration time curve following single and multiple doses of SL-279252. AUC (0-inf; from time 0 to infinity) is reported for C1D1 and C2D1 (Schedule 1 only); AUC (tau; over a dosing interval) is reported for C1D15 and C2D1 (Schedule 2 only).
Measured: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (cycle = 28 days)
Terminal Half Life (t1/2)
The t1/2 elimination half-life of SL-279252
Measured: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (cycle = 28 days)
Clearance
Clearance of SL-279252
Measured: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (cycle = 28 days)
Volume of Distribution
Volume of distribution of SL-279252
Measured: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (cycle = 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start26 Mar 2019
- Primary completion4 May 2023
- Study completion4 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Squamous Cell Carcinoma of the Head and NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shattuck Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shattuck Labs, Study director, Shattuck Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894618
- Sponsor's protocol ID
- SL01-DEL-101
- Status last verified
- Feb 2025
- First submitted
- 10 Jan 2019
- Last updated
- 2 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Johnson M, Hong D, Brana I, Schoffski P, Galvao V, Rangwala F, Ma B, Hernandez R, Kamat A, Kato K, Schreiber TH, Pandite L, Siu LL. First-in-human, phase 1 dose escalation study of SL-279252, a hexameric PD1-Fc-OX40L fusion protein, in patients with advanced solid tumors and lymphoma. Invest New Drugs. 2025 Apr;43(2):284-292. doi: 10.1007/s10637-025-01518-7. Epub 2025 Mar 5.
PubMed 40042547
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Dose Escalation and Dose Expansion Study of an Agonist Redirected Checkpoint Fusion Protein, SL-279252 (PD1-Fc-OX40L), in Subjects With Advanced Solid Tumors or Lymphomas
- ClinicalTrials.gov ID
- NCT03894618
- Acronym / sponsor ID
- SL01-DEL-101
- Conditions
- Squamous Cell Carcinoma of the Head and Neck, Melanoma, Non Small Cell Lung Cancer, Urothelial Carcinoma, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Shattuck Labs, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 4 May 2023 (actual)
- Study completion
- 4 May 2023 (actual)
- First posted
- 28 Mar 2019 (actual)
- Results
- Posted 14 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1 first in human, open label, multi-center, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, anti-tumor activity and pharmacodynamic effects of SL-279252 in subjects with advanced solid tumors or lymphomas.
Detailed description
This is a Phase 1 first in human, open label, multi-center, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, anti-tumor activity and pharmacodynamic effects of SL-279252 in subjects with advanced solid tumors or lymphomas. The study design consists of Dose Escalation and Dose Expansion Cohorts. In the dose escalation phase of the study, subjects will be enrolled into sequential dose levels. During dose escalation, two possible schedules for administration of SL-279252 may be explored. The MTD or MAD may be determined for either schedule. Based on accumulating data from the dose escalation phase, including safety, PK, pharmacodynamic and anti-tumor activity, up to two dose expansion cohorts may be opened. The primary objective of the expansion phase is to further refine the safety and tolerability of SL-279252. The expansion cohorts will evaluate one or two doses of SL-279252 using one selected schedule. At the end of dose escalation and dose expansion, safety, PK, anti-tumor activity, and pharmacodynamic data will be reviewed to identify the RP2D.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SL-279252 | Experimental | Drug: SL-279252Intravenous administration; Two possible dosing schedules for SL-279252 may be evaluated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Participants are eligible to be included in the study only if all the following criteria apply.
- Subject has voluntarily agreed to participate by giving written informed consent in accordance with ICH/GCP guidelines and applicable local regulations.
- Subject has a histologically confirmed diagnosis of one of the following unresectable locally advanced or metastatic malignancies: melanoma, non-small cell lung cancer (squamous, adeno, or adeno-squamous), urothelial cancer, squamous cell carcinoma of the head and neck, squamous cell cervical cancer, gastric or gastro-esophageal junction adenocarcinoma, squamous cell carcinoma of the anal canal, squamous cell carcinoma of the skin, renal cell cancer, Hodgkin's lymphoma, and microsatellite instability high (MSI-H) or mismatch repair deficient (MMRD) solid tumors excluding CNS malignancies. MSI and MMRD testing results as per institution is acceptable.
- Subject must have received, been intolerant to, or is ineligible for standard therapy (per local guidelines and approvals) or have a malignancy for which there is no approved therapy considered standard of care.
- Age 18 years and older.
Key exclusion criteria (31 listed)
- Has received more than two prior checkpoint inhibitor containing treatment regimens (regimen refers to either monotherapy or combination immunotherapies) or has had prior treatment with an OX40 agonist.
- Refractory to last PD-1/L1 inhibitor-based therapy which is defined as disease progression within 3 months of treatment initiation.
- Any anti-cancer therapy within the time intervals noted below prior to first dose (D1) of SL-279252.
- Therapy Washout period Chemotherapy 3 weeks Hormonal therapy 3 weeks PD-1/L1 inhibitor and other immunotherapies not otherwise specified 3 weeks Tumor vaccine 4 weeks Cell-based therapy 8 weeks Other mAbs or biologic therapies 3 weeks Major surgery 2 weeks Radiation (except palliative intent which does not require washout) 2 weeks
- Concurrent chemotherapy, immunotherapy, biologic or hormonal therapy is prohibited. Concurrent use of hormones for non-cancer related conditions is acceptable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SL-279252The investigational product (IP), SL-279252, is a first-in-class agonist redirected checkpoint (ARC) fusion protein (FP) consisting of the extracellular domains of human programmed cell death 1 (PD- 1) and OX40L, linked by a central Fc domain (PD1-Fc-OX40L). | Drug | SL-279252 |
Primary outcome
Safety Profile of SL-279252
Time frame: From Day 1 to 90 days after Last Dose of SL-279252
Number of participants with treatment emergent adverse events
Maximum Tolerated Dose (MTD) of SL-279252
Time frame: From Day 1 to Day 21 (Schedule 1) or Day 28 (Schedule 2)
Number of participants with dose limiting toxicities (DLTs)
10 secondary outcomes
Recommended Phase 2 Dose for SL-279252
Time frame: Approximately 32 months
Overall Response Rate of SL-279252
Time frame: Approximately 32 months
Immunogenicity to SL-279252
Time frame: Approximately 32 months
Maximum Serum Concentration (Cmax) of SL-279252
Time frame: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (cycle = 28 days)
Minimum Serum Concentration (Cmin) of SL-279252
Time frame: Cycle 1 Day 15 and Cycle 2 Day 1 (cycle = 28 days)
Time at Which Maximum Concentration of SL-279252 is Observed (Tmax)
Time frame: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (cycle = 28 days)
Area Under the Serum Concentration-time Curve (AUC)
Time frame: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (cycle = 28 days)
Terminal Half Life (t1/2)
Time frame: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (cycle = 28 days)
Clearance
Time frame: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (cycle = 28 days)
Volume of Distribution
Time frame: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (cycle = 28 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40042547Johnson M, Hong D, Brana I, Schoffski P, Galvao V, Rangwala F, Ma B, Hernandez R, Kamat A, Kato K, Schreiber TH, Pandite L, Siu LL. First-in-human, phase 1 dose escalation study of SL-279252, a hexameric PD1-Fc-OX40L fusion protein, in patients with advanced solid tumors and lymphoma. Invest New Drugs. 2025 Apr;43(2):284-292. doi: 10.1007/s10637-025-01518-7. Epub 2025 Mar 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shattuck Labs study director
Shattuck Labs
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SL-279252 in people with Squamous Cell Carcinoma of the Head and Neck and Melanoma, run by Shattuck Labs, Inc. at 5 sites in 4 countries.
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 25 inclusion and 31 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 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Belgium, Canada, Spain. 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?
Yes. Results are posted in the registry (first posted 14 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Safety Profile of SL-279252 (time frame: From Day 1 to 90 days after Last Dose of SL-279252). The study lists 2 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 NCT03894618, which also lists 1 linked publication.
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 2 Apr 2025.