DZD6008 for Lung Cancer

Recruiting at 4 trial locations

Overseen By Yifan Liu

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Dizal Pharmaceuticals

Must not be taking: Immunotherapy, Anticancer drugs, Proton pump inhibitors, others

Disqualifiers: Uncommon EGFR mutations, SCLC, Uncontrolled hypertension, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 18

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, DZD6008, for safety and effectiveness in treating non-small cell lung cancer (NSCLC) with specific EGFR mutations. Participants will receive varying doses to determine the optimal one. Suitable candidates have advanced NSCLC with specific EGFR mutations and have previously tried at least one other EGFR-targeting treatment without success. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.

Do I have to stop taking my current medications for the trial?

You may need to stop taking certain medications before joining the trial. Specifically, if you are taking drugs that affect the enzyme CYP3A4 or proton pump inhibitors, you will need to stop them for a period of time before starting the study drug. Please discuss your current medications with the study team to see if any changes are needed.

Is there any evidence suggesting that DZD6008 is likely to be safe for humans?

Research shows that DZD6008, a treatment for advanced lung cancer with specific genetic changes (EGFR mutations), is being tested for safety and efficacy. Detailed safety results from completed studies are not yet available, as the current trial is in its early stages. Researchers are primarily determining the appropriate dose and assessing patient tolerance. Early trials often involve close monitoring for side effects. If DZD6008 proves safe at these initial doses, it may progress to further studies to gather additional safety information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lung cancer?

Researchers are excited about DZD6008 for lung cancer because it offers a novel approach compared to existing treatments like chemotherapy, targeted therapy, and immunotherapy. Most lung cancer treatments target cancer cells directly or enhance the immune system's ability to fight cancer. However, DZD6008 is believed to work by a unique mechanism that could potentially target cancer cells more precisely, reducing damage to healthy cells and possibly leading to fewer side effects. Additionally, the treatment is being tested in various doses to find the most effective and safest option, which could provide a tailored approach to patient care. This has the potential to improve outcomes for patients who might not respond well to current therapies.

What evidence suggests that DZD6008 might be an effective treatment for lung cancer?

Research has shown that DZD6008 is a promising treatment for advanced non-small cell lung cancer (NSCLC) with specific changes in the EGFR gene. Studies have found that DZD6008 blocks the EGFR protein, which often mutates in lung cancer and promotes its growth. This treatment is a 4th-generation EGFR TKI, designed to be precise and capable of reaching the brain. As a result, it might also help treat cancer that has spread to the brain. Early results suggest that DZD6008 could be effective for patients whose cancer no longer responds to earlier treatments. Participants in this trial will receive DZD6008 in various dose escalation cohorts to determine the optimal dosing. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for patients with advanced non-small cell lung cancer (NSCLC) who have specific EGFR mutations. Detailed eligibility criteria are not provided, but typically participants would need to meet certain health standards and mutation profiles.

Inclusion Criteria

I am mostly active and my doctor expects me to live 12 weeks or more.

My brain metastases are stable.

My blood counts and organ functions are within normal ranges.

Exclusion Criteria

I do not have any conditions that affect how my body absorbs medication.

I have or had interstitial lung disease.

I have not received a live vaccine in the last 2 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part A: Dose Escalation

Locally advanced or metastatic NSCLC patients with EGFR sensitizing mutations receive escalating doses of DZD6008

21 weeks

7 cycles, each cycle is 21 days

Part B: Dose Expansion

Patients with EGFR sensitizing mutations and C797X mutation receive selected doses of DZD6008

33 weeks

11 cycles, each cycle is 21 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DZD6008

Trial Overview The study focuses on the safety and effectiveness of DZD6008, an oral medication targeting the EGFR pathway in NSCLC. It's likely a phase trial where dosage and response are closely monitored.

How Is the Trial Designed?

Group I: Experimental: Part B Dose Expansion cohorts (selected dose 2 QD) Experimental Treatment 1 Intervention

Group II: Experimental: Part B Dose Expansion cohorts (selected dose 1 QD) Experimental Treatment 1 Intervention

Group III: Experimental: Part A Dose Escalation cohorts (90 mg QD) Experimental Treatment 1 Intervention

Group IV: Experimental: Part A Dose Escalation cohorts (60 mg QD) Experimental Treatment 1 Intervention

Group V: Experimental: Part A Dose Escalation cohorts (40 mg QD) Experimental Treatment 1 Intervention

Group VI: Experimental: Part A Dose Escalation cohorts (20 mg once daily [QD]) Experimental Treatment 1 Intervention

Group VII: Experimental: Part A Dose Escalation cohorts (150 mg QD) Experimental Treatment 1 Intervention

Group VIII: Experimental: Part A Dose Escalation cohorts (120 mg QD) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Dizal Pharmaceuticals

Lead Sponsor

Trials

27

Recruited

2,500+

Published Research Related to This Trial

In a phase II study involving 30 patients with advanced HER2 exon 20 mutant non-small-cell lung cancer (NSCLC), poziotinib demonstrated a confirmed objective response rate of 27%, indicating its potential effectiveness as a targeted therapy.

The treatment was associated with a median overall survival of 15 months and a median progression-free survival of 5.5 months, although it also had notable side effects, including skin rash and diarrhea, with one possible treatment-related death from pneumonitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Poziotinib for Patients With HER2 Exon 20 Mutant Non-Small-Cell Lung Cancer: Results From a Phase II Trial. Elamin, YY., Robichaux, JP., Carter, BW., et al.[2023]

The combination of mocetinostat (70 mg TIW) and durvalumab was generally well tolerated in patients with advanced non-small cell lung cancer (NSCLC), with an objective response rate (ORR) of 11.5% across all phase II cohorts, indicating some effectiveness in this challenging population.

Notably, the treatment showed a higher ORR of 23.1% in patients whose disease was refractory to prior checkpoint inhibitor therapies, suggesting that mocetinostat may help overcome resistance to existing treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mocetinostat in Combination With Durvalumab for Patients With Advanced NSCLC: Results From a Phase I/II Study. Johnson, ML., Strauss, J., Patel, MR., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06905197

NCT06905197 | A Multinational Study Assessing an Oral ... This study is designed to evaluate safety and anti-tumor activity of DZD6008 in patients with advanced NSCLC with EGFR mutations. Detailed Description. The ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.8616

Phase I/II study of DZD6008, a 4th-generation EGFR TKI ... Background: NSCLC patients whose disease progressed after 3rd generation EGFR TKI treatment often have CNS metastasis and acquired EGFR ...

3. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/573695

Assessing an Oral EGFR Inhibitor, DZD6008 in Patients ... This study is designed to evaluate safety and antitumor activity of DZD6008 in patients with advanced NSCLC with EGFR mutations.

4. withpower.com withpower.com/trial/phase-1-carcinoma-non-small-cell-lung-5-2025-943ff

DZD6008 for Lung Cancer This study is designed to evaluate safety and anti-tumor activity of DZD6008 in patients with advanced NSCLC with EGFR mutations.

5. prnewswire.com prnewswire.com/news-releases/dizal-to-showcase-data-in-hematologic-malignancies-and-lung-cancer-at-asco-2025-302437224.html

Dizal to Showcase Data in Hematologic Malignancies and ... DZD6008 is a novel, highly selective, full-BBB penetrant EGFR TKI, designed as a potential treatment option for advanced EGFR mutation positive ...

6. cancer.columbia.edu cancer.columbia.edu/cancer-types-care/clinical-trials/find-clinical-trial/phase-1-open-label-multicenter-study-assess-safety-tolerability-pharmacokinetics-and-anti-tumor-efficacy-dzd6008-patients-advanced-non-small-cell-lung-cancer-nsclc-egfr-mutation-tian-shan1

A Phase 1, Open-Label, Multicenter Study to Assess the ... This study is evaluating the study drug, DZD6008, in patients with advanced non small cell lung cancer (NSCLC) harboring an epidermal growth factor receptor ( ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07070440

Study Details | NCT07070440 | DZD6008 Combination ... A Phase 1/2, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD6008 Combination Therapy in ...

8. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/573695

Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who ... This study is designed to evaluate safety and antitumor activity of DZD6008 in patients with advanced NSCLC with EGFR mutations.