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Monoclonal Antibodies
Anti-CD38 Antibody Drug for Advanced Cancer
Phase 1
Waitlist Available
Research Sponsored by Sorrento Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through study completion at up to approximately 24 months
Awards & highlights
Study Summary
This trial will test a new drug to treat advanced solid tumors in people who have already tried other treatments.
Who is the study for?
This trial is for adults with advanced solid tumors who have tried other treatments without success. They must have good blood, kidney, and liver function, be able to follow the study plan, use contraception if needed, and not have had certain severe health issues or recent anti-CD38 treatment.Check my eligibility
What is being tested?
The trial tests STI-6129 in patients with advanced solid tumors to find a safe dose and see how well it works. It's an early-phase study (Phase 1b) that looks at safety, effectiveness against cancer, and immune response.See study design
What are the potential side effects?
Potential side effects of STI-6129 are not detailed here but may include typical reactions related to immune therapies such as infusion reactions, fatigue, allergic responses or organ inflammation based on its mechanism of action.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through study completion at up to approximately 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through study completion at up to approximately 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events by type, frequency, severity, and causality (safety)
Incidence of dose-limiting toxicities (safety)
Incidence of laboratory abnormalities (safety)
+2 moreSecondary outcome measures
Evaluation of response rate
Overall duration
Overall response
Side effects data
From 2021 Phase 1 & 2 trial • 331 Patients • NCT0225756767%
FATIGUE
50%
ALOPECIA
50%
DECREASED APPETITE
50%
CONSTIPATION
50%
NAUSEA
50%
INSOMNIA
33%
HYPOPHOSPHATAEMIA
33%
RASH
33%
NEUTROPENIA
33%
VOMITING
33%
NIGHT SWEATS
33%
DIARRHOEA
33%
WEIGHT DECREASED
33%
HYPERGLYCAEMIA
33%
DYSPNOEA
17%
PLATELET COUNT DECREASED
17%
PRURITUS
17%
ARTHROPOD BITE
17%
SKIN DISCOLOURATION
17%
THROMBOCYTOPENIA
17%
HYPERTENSION
17%
GLAUCOMA
17%
STOMATITIS
17%
CHILLS
17%
FOLLICULITIS
17%
BONE PAIN
17%
HERPES ZOSTER
17%
INFUSION RELATED REACTION
17%
LYMPHOCYTE COUNT DECREASED
17%
HYPOMAGNESAEMIA
17%
HYPOKALAEMIA
17%
NEUROPATHY PERIPHERAL
17%
PERIPHERAL SENSORY NEUROPATHY
17%
EYE PRURITUS
17%
VISION BLURRED
17%
FLATULENCE
17%
SINUSITIS
17%
ENDOMETRIAL ADENOCARCINOMA
17%
ENDOMETRIAL CANCER
17%
ANAEMIA
17%
ABDOMINAL PAIN
17%
MUSCULAR WEAKNESS
17%
COUGH
17%
DYSPNOEA EXERTIONAL
17%
DRY SKIN
17%
MOUTH ULCERATION
17%
PALLOR
17%
EYE DISCHARGE
17%
VITAMIN D DEFICIENCY
17%
SINUS CONGESTION
17%
ATRIAL FIBRILLATION
17%
PYREXIA
17%
DIZZINESS
17%
PERIPHERAL SWELLING
17%
HODGKIN'S DISEASE
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL
Arm A (Phase II Randomization): Pola+BR in FL
Arm B (Phase II Randomization): BR in FL
Arm C (Phase II Randomization): Pola+BR in DLBCL
Arm D (Phase II Randomization): BR in DLBCL
Arm E (Phase II Expansion): Pola+BG in FL
Arm F (Phase II Expansion): Pola+BG in DLBCL
Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL
Trial Design
1Treatment groups
Experimental Treatment
Group I: STI-6129 infusionExperimental Treatment1 Intervention
Intravenous infusion to be given with prophylaxis for infusion reactions if necessary.
Find a Location
Who is running the clinical trial?
Sorrento Therapeutics, Inc.Lead Sponsor
47 Previous Clinical Trials
1,930 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had any other cancer treatments in the last 3 years.My cancer is one of the specified types and has not responded to standard treatments.I have brain metastases or CNS disease that hasn't been treated or is causing symptoms.I have not recently used any cancer drugs or been part of a drug trial.My blood, kidney, and liver tests are within normal ranges.I have completed at least 2 standard treatments for my MSS-CRC.I am not taking medication that affects liver enzymes.I am fully active or can carry out light work.I have a history of conditions like muscle weakness, eye issues, immune reactions, nerve damage, heart problems, abnormal heart rhythm, or brain diseases.I have not had anti-CD38 treatment in the last 90 days.
Research Study Groups:
This trial has the following groups:- Group 1: STI-6129 infusion
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.
To what degree does STI-6129 infusion present a hazard to individuals?
"Due to the fact that this is an early phase 1 trial, with limited data regarding its efficacy and safety profile, STI-6129 infusion received a score of 1."
Answered by AI
Are there opportunities for participants to join this research endeavor presently?
"As per the data accessible through clinicaltrials.gov, this particular medical trial is not currently in need of participants. The study was initially posted on March 1st 2023 and its last update came October 13th 2022. However, there are 2,503 other studies actively recruiting people for participation at this time."
Answered by AI
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