AQUA07 in Patients With ALK-Positive Non-Small Cell Lung Cancer
A Phase I, Open-Label, Multicenter, Dose Escalation and Cohort Expansion Study of AQUA07 Monotherapy and Combination Therapy in Patients With Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests AQUA07 alone and with lorlatinib in adults with ALK-positive non-small cell lung cancer, a cancer with a change in the ALK gene. It is the first study of AQUA07 in humans and checks its safety, how it works in the body, and its effect on cancer. It is for people whose cancer has grown or spread and who have already taken ALK-targeted treatment.
This is a first-in-human, Phase I, open-label, multicenter, multinational study, designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of AQUA07 when administered as single agent and in combination with lorlatinib in patients with ALK positive non-small cell lung cancer.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be at least 18 years old, or 20 if local rules require it, when signing the consent form.
- Have taken at least one ALK-blocking drug. You cannot join if crizotinib is the only ALK-blocking drug you have taken.
- Have ALK-positive non-small cell lung cancer confirmed by a tissue or cell test, not a mucus sample. The cancer must have spread nearby and cannot be removed by surgery, or have spread to other parts of the body.
- Your cancer got worse during or after your latest whole-body cancer treatment, or you stopped that treatment because of side effects.
- Have cancer that can be measured using the study's rules.
- Be fully active or able to do light work, even if you cannot do hard physical activity.
- Be able and willing to take medicine by mouth.
- Have organs that work well enough and bone marrow that makes enough blood cells.
Who can't join
- Have side effects from past cancer treatment that are still more than mild. Hair loss, loss of skin color, and hormone problems managed with replacement hormones are allowed.
- Have active cancer spread to the brain or spinal cord that causes symptoms, or untreated spread there that needs treatment.
- Have a severe illness that is not controlled, such as serious heart, lung, or kidney disease, or an active infection.
- Have a history of or problems from interstitial lung disease, which can cause lung inflammation or scarring.
- Have significant heart or blood vessel disease.
- Have high blood pressure that is not well controlled.
- For Part B only: have had serious side effects from lorlatinib, or side effects that the study doctor believes make joining unsafe.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Age ≥ 18 years (or ≥ 20 years if required by local regulation) at time of signing Informed Consent Form * Previously treated with at least one ALK-TKI regardless of prior chemotherapy treatment (Patients who have received only crizotinib as prior ALK-TKI treatment will not be allowed.) * Histologically or cytologically (excluding sputum cytology) proven diagnosis of locally advanced unresectable or metastatic ALK-positive NSCLC, who have experienced disease progression during or following their most recent systemic therapy or have discontinued the therapy due to unacceptable toxicity * Measurable disease per RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Ability and willingness to take oral medication(s) * Adequate organ function and bone marrow reserve Exclusion Criteria: * Prior toxicities from anti-cancer therapy which have not resolved to Grade ≤ 1 per NCI CTCAE v5.0 excluding alopecia, vitiligo, or endocrinopathies manageable with replacement therapy * Symptomatic, active CNS metastases or untreated CNS metastases requiring any definitive therapy. * Severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or renal disease, or active infection), or with a history or complication of interstitial lung disease * Significant cardiovascular disease * Inadequately controlled hypertension * (Part B only) Patients with prior lorlatinib treatment who experienced serious lorlatinib-related toxicities, or who experienced toxicities considered inappropriate for study participation at the discretion of the Investigator
Study sites (1)
TX
- The University of Texas MD Anderson Cancer Center · Houston, TX 77030More trials in Houston