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Small Molecule
SX-682 + Pembrolizumab for Melanoma
Phase 1
Recruiting
Research Sponsored by Syntrix Biosystems, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Prior disease progression on anti-PD1 therapy with specific timing and adverse event criteria.
Histologically confirmed unresectable Stage III or Stage IV melanoma as per AJCC staging system (mucosal melanoma is acceptable).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 38-42 of each 42 day combination stage cycle (cycles 1-17)
Awards & highlights
Study Summary
This trial will test if a new drug, SX-682, can help fight cancer by blocking cells that keep the immune system from attacking the cancer.
Who is the study for?
Adults over 18 with advanced melanoma that has worsened after anti-PD1 therapy can join. They must understand the study, agree to follow its rules, and have a life expectancy over 12 weeks. Women who can get pregnant and men with partners who can must use contraception. People with certain health conditions or treatments are excluded.Check my eligibility
What is being tested?
The trial is testing SX-682's ability to block cells that shield cancer from our immune system in patients with metastatic melanoma, alongside pembrolizumab (an approved treatment). Initially, SX-682 alone is given for 21 days followed by up to two years of combined treatment.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system's increased activity against cancer cells due to SX-682 and pembrolizumab. These could range from mild skin reactions or flu-like symptoms to more serious organ inflammation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition worsened after anti-PD1 therapy without severe side effects.
Select...
My melanoma is at an advanced stage and cannot be surgically removed.
Select...
I have a tumor outside the brain that can be measured.
Select...
I am fully active or can carry out light work.
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I am a woman under 62 and have a high FSH level, indicating I am postmenopausal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 38-42 of each 42 day combination stage cycle (cycles 1-17)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 38-42 of each 42 day combination stage cycle (cycles 1-17)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival
Progression free survival
SX-682 Maximum Tolerated Dose (MTD) during Monotherapy Stage
+3 moreSecondary outcome measures
Adverse events during Monotherapy Stage
Adverse events during combination Therapy Stage
SX-682 dose limiting toxicities (DLTs) during combination therapy stage
+3 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
2Treatment groups
Experimental Treatment
Group I: Monotherapy: SX-682 dose escalationExperimental Treatment1 Intervention
Escalating oral doses of SX-682 (study drug) of 25, 50, 100, 200 and 400 mg twice-daily (i.e., 50, 100, 200, 400 and 800 mg total each day.
Group II: Combination therapy: SX-682 dose escalation with pembrolizumabExperimental Treatment2 Interventions
SX-682 will be administrated at the same dose the participant was administered in monotherapy and will be administered in a 6 week cycle that includes 2 i.v. infusions of pembrolizumab on days 1 and 22 of each cycle, for a total of up to 17 cycles. Once the highest safe dose of SX-682 in combination therapy with pembrolizumab is determined, participants will be enrolled in an expansion phase at that SX-682 dose with pembrolizumab combination therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Syntrix Biosystems, Inc.Lead Sponsor
13 Previous Clinical Trials
730 Total Patients Enrolled
University of MiamiOTHER
902 Previous Clinical Trials
409,939 Total Patients Enrolled
5 Trials studying Melanoma
1,888 Patients Enrolled for Melanoma
Mayo ClinicOTHER
3,212 Previous Clinical Trials
3,766,961 Total Patients Enrolled
40 Trials studying Melanoma
2,446 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have tested positive for HIV/AIDS.My condition worsened after anti-PD1 therapy without severe side effects.You are required to stay in a hospital or treatment center for a mental or physical illness.I have an autoimmune disease, but it may be one of the exceptions.My melanoma is at an advanced stage and cannot be surgically removed.I am a man and will use contraception if I'm sexually active with a woman who can become pregnant.I haven't taken steroids or immunosuppressants in the last 14 days.I have stopped taking any medications that can affect my heart's rhythm for two weeks.I have a tumor outside the brain that can be measured.I have not had major surgery in the last 4 weeks.My melanoma is not in the eye, but mucosal melanoma is okay.I have not had any cancer, except for treatable local cancers, in the last 3 years.You have a positive test for hepatitis B or hepatitis C virus, showing that you have an ongoing infection.I finished my radiotherapy at least 2 weeks ago.I have a tissue sample from my cancer that can be tested.My heart's electrical activity shows a longer than normal pause.I am not pregnant, as confirmed by a test.I have not received a live-virus vaccine in the last 30 days.I am not pregnant or breastfeeding.I have brain metastases but meet certain conditions for treatment.I am older than 18 years.I am fully active or can carry out light work.Your recent blood test results need to meet certain standards and should have been done within the last 14 days before starting the study.You do not have HIV, Hepatitis B, or Hepatitis C.You are expected to live for at least 12 more weeks.I am a woman under 62 and have a high FSH level, indicating I am postmenopausal.Women must have a negative pregnancy test within 24 hours before starting the study drug.
Research Study Groups:
This trial has the following groups:- Group 1: Combination therapy: SX-682 dose escalation with pembrolizumab
- Group 2: Monotherapy: SX-682 dose escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has SX-682 attained regulatory approval from the Food and Drug Administration?
"Limited clinical data surrounding SX-682's safety and efficacy means that our team at Power has rated its risk level as a 1 on the scale of 1 to 3."
Answered by AI
What is the limit for patient recruitment in this research endeavor?
"The clinical trial necessitates 77 participants that fit into the study's eligibility criteria. Syntrix Biosystems, Inc., is managing this investigation from Massachusetts General Hospital Cancer Center in Boston and MD Anderson in Houston, Texas."
Answered by AI
Are there any available slots for participants in this investigation?
"Affirmative. According to clinicaltrials.gov, this study was first launched on June 12th 2019 and is still actively recruiting patients as of January 26th 2022. A total of 77 participants need to be recruited from 5 different sites."
Answered by AI
Are there any other experiments that have used SX-682 as a primary component?
"Currently, there are 961 live studies surrounding SX-682 with 122 trials in the third phase. Although many of these research initiatives take place in Houston, Texas, a total of 35731 sites throughout the world have been enlisted to conduct experiments regarding this drug."
Answered by AI
What are the anticipated outcomes of this research endeavor?
"According to the sponsors of this trial, Syntrix Biosystems Inc., their main focus is on gauging the maximum tolerated dose over a 17 cycle period and 90 days after final SX-682 ingestion. Secondary assessment criteria include potential adverse reactions throughout monotherapy periods, pharmacokinetic parameters during single dosing and combination therapy, as well as any dose limiting toxicities during combined intervention stages."
Answered by AI
What are the common therapeutic applications of SX-682?
"SX-682 is regularly employed to treat malignant neoplasms, but can also be applied in the management of unresectable melanoma, microsatellite instability high cases and those with disease progression after chemotherapy."
Answered by AI
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