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Monoclonal Antibody

TLR9 Agonist SD-101 for Cancer

Phase 1

Waitlist Available

Led By Saad A Khan

Research Sponsored by Ronald Levy

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 up to 3 years

Awards & highlights

Study Summary

This trial is testing the side effects of two drugs, one that stimulates the immune system and one that enhances the activation of T cells, in treating patients with solid tumors.

Eligible Conditions

Cancer
Solid Tumors

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

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 of intratumoral injections of study drugs

Secondary outcome measures

Overall response rate

Progression-Free survival (PFS)

Side effects data

From 2021 Phase 2 trial • 22 Patients • NCT03019640

100%

Lymphocyte count decreased

100%

White blood cell decreased

100%

Nausea

100%

Fever

100%

Platelet count decreased

100%

Anemia

100%

Neutrophil count decreased

95%

Diarrhea

82%

Hyperglycemia

77%

Mucositis oral

77%

Fatigue

64%

Sinus tachycardia

59%

Hypotension

59%

Anorexia

55%

Hypophosphatemia

55%

Constipation

55%

Edema limbs

55%

Rash maculo-papular

50%

Headache

45%

Hypoalbuminemia

45%

Hypocalcemia

45%

Alanine aminotransferase increased

41%

Hypokalemia

41%

Dizziness

36%

Hyponatremia

36%

Anxiety

32%

Investigations

32%

Insomnia

32%

Vomiting

32%

Chills

32%

Cough

32%

Febrile neutropenia

32%

Hypertension

27%

Pain

27%

Alkaline phosphatase increased

27%

Aspartate aminotransferase increased

23%

Hypomagnesemia

23%

Infections and infestations

23%

Dysphagia

23%

Arthralgia

23%

Esophagitis

23%

Hiccups

18%

Dehydration

18%

Hypoxia

18%

Abdominal pain

18%

Allergic rhinitis

18%

Dyspnea

18%

Generalized muscle weakness

18%

Hemorrhoids

14%

Infusion related reaction

14%

INR increased

14%

Immune system disorders

14%

Bloating

14%

Paresthesia

14%

Pleural effusion

14%

Dyspepsia

14%

Hypermagnesemia

14%

Rectal pain

Upper respiratory infection

Sore throat

Blood bilirubin increased

Bone pain

Cholesterol high

Creatinine increased

Nasal congestion

Papulopustular rash

Arthritis

Back pain

Dry skin

Dysgeusia

Flushing

General disorders and administration site conditions

Hypernatremia

Hyperuricemia

Non-cardiac chest pain

Renal and urinary disorders

Skin ulceration

Hypoglycemia

Lymph node pain

Tremor

Hypothyroidism

Lung infection

Thromboembolic event

Urinary tract pain

Vascular disorders

Weight gain

Lymphocyte count increased

Myalgia

Urinary tract infection

Urinary frequency

Lung

Eye disorders

Gastroesophageal reflux disease

Mucosal infection

Metabolism and nutrition disorders

Musculoskeletal and connective tissue disorder

Peripheral motor neuropathy

Prostatic obstruction

Pulmonary edema

Rash acneiform

Respiratory failure

Acute kidney injury

Ear pain

Edema face

Encephalopathy

Endocrine disorders

Atelectasis

Atrial fibrillation

Bladder infection

Epistaxis

Flatulence

Gastrointestinal pain

Hematuria

Hemorrhoidal hemorrhage

Hypercalcemia

Neck pain

Nervous system disorders

Pain in extremity

Restlessness

Sinus bradycardia

Sinusitis

Skin and subcutaneous tissue disorder

Skin hyperpigmentation

Ileus

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Chemotherapy, NK Infusion, Stem Cell Transplant)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (SD-101, BMS-986178)Experimental Treatment2 Interventions

SAFETY COHORT: Patients receive TLR9 agonist SD-101 IT on days 1, 8 and 15. Patients also receive anti-OX40 antibody BMS 986178 IT on days 8 and 15, and IV over 30 minutes on days 8, 29 and 58. EXPANSION COHORT: Patients receive TLR9 agonist SD-101 IT on days 1, 8 and 15. Patients also receive anti-OX40 antibody BMS 986178 IT on days 1, 8 and 15, and IV over 30 minutes on days 1, 29 and 58.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Anti-OX40 Antibody BMS 986178

2019

Completed Phase 1

~20

TLR9 Agonist SD-101

2016

Completed Phase 2

~40

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ronald LevyLead Sponsor

4 Previous Clinical Trials

134 Total Patients Enrolled

Bristol-Myers SquibbIndustry Sponsor

2,638 Previous Clinical Trials

4,128,502 Total Patients Enrolled

Saad A KhanPrincipal InvestigatorStanford Cancer Institute Palo Alto

1 Previous Clinical Trials

20 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Food and Drug Administration approved TLR9 Agonist SD-101?

"As it is only a Phase 1 trial, there has been limited research to assess the safety of TLR9 Agonist SD-101. Hence, our team at Power gave this medication a score of 1."

Answered by AI

Are there any historical reports which discuss the efficacy of TLR9 Agonist SD-101?

"At the present time, two active clinical trials for TLR9 Agonist SD-101 are in progress. Neither of these is at Phase 3 yet. Most of those studies are being conducted in Palo Alto, California; however, there are some other sites involved as well."

Answered by AI

Are there still any vacancies available for participants of this experiment?

"This clinical trial is currently not recruiting new participants. Initially posted on March 13th 2019, with the most recent update occuring June 13th 2022, those seeking to join will have to look elsewhere. Fortunately, 2395 trials are presently active for extracranial solid neoplasms and 2 SD-101 TLR9 Agonist studies require patients too."

Answered by AI

What is the scope of enrollment for this clinical trial?

"The enrollment period for this trial has ended, and the study was last updated on June 13th 2022. However, if you are still researching potential trials to join, there are currently 2395 studies seeking participants with extracranial solid neoplasms and 2 clinical trials actively recruiting patients who have been treated with TLR9 Agonist SD-101."

Answered by AI

Recent research and studies

Cancer ResearchJournal

Neoadjuvant Intratumoral Immunotherapy with TLR9 Activation and Anti-ox40 Antibody Eradicates Metastatic Cancer

Hong, Wan Xing, Idit Sagiv-Barfi, Debra K. Czerwinski, Adrienne Sallets, and Ronald Levy. 2022. “Neoadjuvant Intratumoral Immunotherapy with TLR9 Activation and Anti-ox40 Antibody Eradicates Metastatic Cancer”. Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/0008-5472.can-21-1382.

clinicaltrials.govStudy

SD-101 and BMS-986178 in Treating Patients With Advanced or Metastatic Solid Malignancies

Ronald Levy 2019. "SD-101 and BMS-986178 in Treating Patients With Advanced or Metastatic Solid Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03831295.