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Small Molecule Inhibitor

BDTX-1535 + Temozolomide for Glioblastoma and Lung Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Black Diamond Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmed NSCLC, without small cell lung cancer transformation
Locally advanced or metastatic disease, with or without central nervous system metastases
Must not have
Known resistant mutations
Treated with a prior EGFR inhibitor (for GBM patients only)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, approximately 1 year
Awards & highlights

Summary

This trial is testing a new drug for people with glioblastoma or non-small cell lung cancer who have disease progression following standard of care.

Who is the study for?
Adults with advanced lung cancer (NSCLC) having specific EGFR mutations or glioblastoma (GBM) expressing EGFR alterations can join. They must have measurable disease, completed standard treatments like surgery and chemotherapy, and be in stable condition post-treatment. Not eligible if they have certain resistant mutations, brain complications needing urgent care, active hepatitis B/C or HIV, recent major surgery, ongoing cancer therapy other than for NSCLC/GBM.
What is being tested?
BDTX-1535 is being tested both alone and combined with temozolomide to see its safety and effectiveness against lung cancer and glioblastoma with EGFR mutations. Patients will take the drug(s) in cycles of 21 or 28 days to assess how well it works on tumors including those spread to the brain.
What are the potential side effects?
Possible side effects are not detailed but typically include reactions related to immune system activation such as fatigue, nausea, skin issues; organ inflammation; blood count changes; potential impact on liver function; neurological symptoms due to CNS activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer is non-small cell type without any small cell transformation.
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My cancer has spread beyond its original location, possibly to my brain.
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My condition worsened after or I couldn't tolerate standard treatment.
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I have been diagnosed with glioblastoma multiforme (GBM).
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My tumor has EGFR alterations.
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My condition worsened after treatment or I cannot tolerate the treatment.
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My cancer has returned after surgery, radiation, or chemotherapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has mutations known to resist treatment.
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I have been treated with an EGFR inhibitor for my brain cancer.
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I have symptoms or imaging results showing disease in the lining of my brain and spinal cord.
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I need urgent treatment for brain or spinal cord issues due to cancer.
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I have no lasting side effects from previous treatments.
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I have a serious heart condition.
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I have not had major surgery in the last 4 weeks and do not plan any during the study.
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I am currently undergoing or have recently completed radiation therapy.
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I do not have active hepatitis B or C, nor am I an HIV carrier.
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I have severe stomach or bowel problems that are not well-managed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, approximately 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, approximately 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1 Dose Escalation: To determine the maximum tolerated dose (MTD), if one exists, and the preliminary recommended Phase 2 dose(s) (RP2D[s]) of BDTX-1535
Phase 2: To assess antitumor efficacy of BDTX-1535
Secondary outcome measures
Phase 1 and Phase 2: Incidence and severity of treatment-emergent adverse events (TEAEs)
Phase 1 and Phase 2: To characterize the plasma concentration of BDTX-1535 following single and multiple dosing
Phase 1: To assess the effect of food on the plasma concentration of BDTX-1535
+8 more

Side effects data

From 2016 Phase 2 trial • 175 Patients • NCT01055314
36%
Febrile neutropenia
31%
Death NOS
30%
Diarrhea
22%
Pain
21%
Hyperglycemia
16%
Anorexia
16%
Infections and infestations - Other, specify
16%
Alanine aminotransferase increased
14%
Hypokalemia
13%
Nausea
11%
Hyponatremia
10%
Weight loss
9%
Anemia
9%
Aspartate aminotransferase increased
9%
Mucositis oral
9%
Vomiting
9%
Constipation
9%
Dehydration
9%
Hypophosphatemia
8%
Platelet count decreased
8%
Sepsis
7%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
7%
Catheter related infection
7%
Colitis
7%
Abdominal pain
6%
Hypotension
6%
White blood cell decreased
6%
GGT increased
6%
Hypocalcemia
6%
Urinary retention
6%
Hypoalbuminemia
6%
Fever
5%
Typhlitis
5%
Anxiety
5%
Neutrophil count decreased
5%
Urinary tract infection
4%
Peripheral motor neuropathy
4%
Enterocolitis
4%
Lipase increased
4%
Pleural effusion
4%
Serum amylase increased
4%
Skin infection
4%
Epistaxis
4%
Urinary tract obstruction
3%
Blood bilirubin increased
3%
Lymphocyte count decreased
3%
Syncope
3%
Wound infection
3%
Dermatitis radiation
3%
Hypertension
3%
Sinus tachycardia
3%
Edema limbs
3%
Bone pain
3%
Dyspnea
3%
Hematuria
3%
Hypercalcemia
2%
Depressed level of consciousness
2%
Stridor
2%
Upper gastrointestinal hemorrhage
2%
Thromboembolic event
2%
Vulval infection
2%
Allergic reaction
2%
Back pain
2%
Lung infection
2%
Urticaria
2%
Acute kidney injury
2%
Muscle weakness lower limb
2%
Musculoskeletal and connective tissue disorder - Other, specify
2%
Pain in extremity
2%
Peripheral sensory neuropathy
2%
Proctitis
2%
Skin ulceration
2%
Apnea
2%
Stoma site infection
2%
Tumor pain
2%
Left ventricular systolic dysfunction
2%
Pancreatitis
2%
Portal hypertension
2%
Rectal hemorrhage
2%
Creatinine increased
2%
Enterocolitis infectious
2%
Hyperkalemia
2%
Investigations - Other, specify
2%
Abdominal distension
1%
Delirium
1%
Esophageal pain
1%
Heart failure
1%
Vasovagal reaction
1%
Hepatobiliary disorders - Other, specify
1%
Vascular disorders - Other, specify
1%
Anal hemorrhage
1%
Penile pain
1%
Menorrhagia
1%
Sore throat
1%
Tracheitis
1%
Gastrointestinal disorders - Other, specify
1%
Ascites
1%
Soft tissue infection
1%
Bone marrow hypocellular
1%
Seizure
1%
Anaphylaxis
1%
Anal mucositis
1%
Fracture
1%
Hydrocephalus
1%
Device related infection
1%
Tooth infection
1%
Gastric ulcer
1%
Sinusitis
1%
Skin and subcutaneous tissue disorders - Other, specify
1%
Pharyngitis
1%
Pyramidal tract syndrome
1%
Anal ulcer
1%
Depression
1%
Ejection fraction decreased
1%
Rash maculo-papular
1%
Pruritus
1%
Myositis
1%
Nail infection
1%
Pain of skin
1%
Pleuritic pain
1%
Pneumonitis
1%
Pneumothorax
1%
Postoperative hemorrhage
1%
Renal and urinary disorders - Other, specify
1%
Respiratory, thoracic and mediastinal disorders - Other, specify
1%
Salivary duct inflammation
1%
Small intestine infection
1%
Alkaline phosphatase increased
1%
Appendicitis
1%
Spinal fracture
1%
Disseminated intravascular coagulation
1%
Ear and labyrinth disorders - Other, specify
1%
Endocrine disorders - Other, specify
1%
Esophageal stenosis
1%
Esophagitis
1%
Gastric hemorrhage
1%
Gum infection
1%
Tumor lysis syndrome
1%
Upper respiratory infection
1%
Hypertriglyceridemia
1%
Hypoxia
1%
Ileus
1%
INR increased
1%
Laryngeal edema
1%
Multi-organ failure
1%
Myelodysplastic syndrome
1%
Oral hemorrhage
1%
Oral pain
1%
Pulmonary edema
1%
Rectal fistula
1%
Rectal pain
1%
Respiratory failure
1%
Bladder spasm
1%
Chest wall pain
1%
Confusion
1%
Congenital, familial and genetic disorders - Other, specify
1%
CPK increased
1%
Dizziness
1%
Encephalopathy
1%
Eye disorders - Other, specify
1%
Generalized muscle weakness
1%
Hoarseness
1%
Hypernatremia
1%
Hypoglycemia
1%
Hypomagnesemia
1%
Insomnia
1%
Irregular menstruation
1%
Irritability
1%
Joint range of motion decreased cervical spine
1%
Kyphosis
1%
Lethargy
1%
Headache
1%
Laryngeal mucositis
1%
Pelvic pain
1%
Esophageal infection
1%
Abdominal infection
1%
Acidosis
1%
Anal fistula
1%
Fall
1%
Fatigue
1%
Gait disturbance
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab)
Group 2 (Chemotherapy, Radiation Therapy, Temozolomide)

Trial Design

4Treatment groups
Experimental Treatment
Group I: Phase 2 Cohort 3: Treatment Naive NSCLC EGFR Non-Classical Driver MutationsExperimental Treatment1 Intervention
Treatment-naïve (first-line) advanced/metastatic NSCLC with a non-classical driver EGFR mutation (1 cycle of chemotherapy or immune checkpoint inhibitor are permitted)
Group II: Phase 2 Cohort 2: NSCLC EGFR Acquired Resistance (C797S) MutationExperimental Treatment1 Intervention
Advanced/metastatic NSCLC with the acquired resistance C797S EGFR mutation following up to 2 lines of therapy, including only 1 EGFR targeted regimen, which must be a third generation EGFR TKI (eg, osimertinib)
Group III: Phase 2 Cohort 1: NSCLC EGFR Non-Classical Driver MutationsExperimental Treatment1 Intervention
Advanced/metastatic NSCLC with a non-classical driver EGFR mutation following up to 2 lines of therapy with only 1 prior EGFR targeted regimen (third-generation preferred; other approved EGFR inhibitors acceptable)
Group IV: Phase 1 Dose Escalation - Monotherapy (Recruitment Closed)Experimental Treatment1 Intervention
Advanced/metastatic NSCLC with acquired resistance EGFR mutation (eg, C797S), following a 3rd generation EGFR inhibitor in the 1st line setting (in the absence of concurrent T790M). Advanced/metastatic NSCLC with non-classical EGFR mutation (eg, G719X) following standard-of-care therapy with an EGFR inhibitor Recurrent GBM with confirmed EGFR alterations (including amplification, mutation, and/or variant)

Find a Location

Who is running the clinical trial?

Black Diamond Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
191 Total Patients Enrolled
Black Diamond TherapeuticsStudy DirectorBlack Diamond Therapeutics

Media Library

BDTX-1535 (Small Molecule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05256290 — Phase 1 & 2
Lung Cancer Research Study Groups: Phase 2 Cohort 1: NSCLC EGFR Non-Classical Driver Mutations, Phase 2 Cohort 2: NSCLC EGFR Acquired Resistance (C797S) Mutation, Phase 2 Cohort 3: Treatment Naive NSCLC EGFR Non-Classical Driver Mutations, Phase 1 Dose Escalation - Monotherapy (Recruitment Closed)
Lung Cancer Clinical Trial 2023: BDTX-1535 Highlights & Side Effects. Trial Name: NCT05256290 — Phase 1 & 2
BDTX-1535 (Small Molecule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05256290 — Phase 1 & 2
~59 spots leftby Sep 2025
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