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Tests treatment safety and results for Relapsed Advanced Lymphomas
Official title A Study Evaluating the Safety and Efficacy of AUR108 in Patients With Relapsed Advanced Lymphomas (ASHA-1)
ClinicalTrials.gov ID: NCT05984147
What this study is testing
What is AUR108?
AUR108 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for relapsed advanced lymphomas.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- An open-label, first-in-human, Phase 1 study in adult patients with relapsed advanced lymphomas will be done to assess AUR108 safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- Males or females ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1
- Acceptable bone marrow and organ function at screening as described below:
- ANC ≥ 1000/μL (without WBC growth factor support)
- Platelet count ≥ 75,000/μL without transfusion support
You likely can't join if
- Systemic anti-cancer therapy, such as chemotherapy, or biological therapy, immunomodulatory drug therapy, received within the past 28 days or 5...
- Presence of an acute or chronic toxicity resulting from prior anticancer treatment, with the exception of alopecia or nail changes, that has not...
- Definitive Radiotherapy within the last 21 days of Cycle 1 Day 1 (limited field palliative radiation is allowed and no restrictions during the...
- Use of any investigational agent within 28 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.
- Patients with cutaneous lymphomas, mycosis fungoides (MF) or Sézary syndrome (SS).
- Primary CNS lymphoma
See the full eligibility criteria
Who can join
- Males or females ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1
- Acceptable bone marrow and organ function at screening as described below:
- ANC ≥ 1000/μL (without WBC growth factor support)
- Platelet count ≥ 75,000/μL without transfusion support
- Hemoglobin ≥ 9 g/dL (Transfusion is allowed to achieve this Hb)
- Total Bilirubin ≤ 1.5 x ULN; (Patients with known Gilbert's syndrome are allowed with a Total Bilirubin ≤ 2.5 x ULN)
- AST (SGOT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases)
- ALT (SGPT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases)
- Creatinine clearance (CrCl) ≥ 30 mL/min (either measured or estimated by the Cockcroft-Gault formula). (Cockcroft-Gault formula for estimated creatinine clearance [eCrCl]: eCrCl = [140- Age] × Weight [kg] × [0.85 if...
- Ability to swallow and retain oral medications
- Histo-pathological diagnosis of a Non-Hodgkin lymphoma orHodgkin Lymphoma. Note: The lymphoma should be either in Stage III or IV according to Lugano classification (Cheson BD et al, 2014) at screening.
- In the case of people who have lymphoma for which high-dose chemotherapy and autologous stem cell transplantation (HDASCT) is considered a standard curative therapy, eligibility for this study requires that the...
- In the case of people who have lymphoma for which CAR-T therapy is considered a standard therapy, eligibility for this study requires that the people disease has relapsed after CAR-T, or that the subject has refused...
- Evidence of measurable disease as per Lugano Criteria for Lymphoma (Cheson BD et al, 2014).
- Standard curative measures do not exist, and patient must have exhausted all effective therapies, available locally.
- At a minimum, the patients must have received at least 2 prior lines of systemic therapies. These systemic therapies could be either in the stage II, III or IV.
- Any cancer patient with access to any effective therapy must not be enrolled.
What rules you out
- Systemic anti-cancer therapy, such as chemotherapy, or biological therapy, immunomodulatory drug therapy, received within the past 28 days or 5 half-lives, whichever is longer, from the Cycle 1 Day 1 of the study. Note...
- Presence of an acute or chronic toxicity resulting from prior anticancer treatment, with the exception of alopecia or nail changes, that has not resolved to Grade ≤ 1, as determined by NCI CTCAE v 5.0.
- Definitive Radiotherapy within the last 21 days of Cycle 1 Day 1 (limited field palliative radiation is allowed and no restrictions during the screening period or during the trial).
- Use of any investigational agent within 28 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.
- Patients with cutaneous lymphomas, mycosis fungoides (MF) or Sézary syndrome (SS).
- Primary CNS lymphoma
- Known symptomatic or untreated or recently treated (≤ 6 months of screening) central nervous system (CNS) lymphoma. Patients with previously treated (\> 6 months of screening) CNS lymphoma and are now stable and...
- Patients with lymphoma that requires immediate cytoreductive therapy
- Patients with lymphoma that requires immediate cytoreductive therapy
- Patients on the drugs which are sensitive substrates of CYP2C8 and cannot be discontinued at least one week prior to Cycle 1 Day 1
- Patients on the drugs which are sensitive substrates of either Poglycoprotein (P-gp) or breast cancer resistance protein (BCRP) and cannot be discontinued at least one week prior to Cycle 1 Day 1
- Major surgery ≤ 28 days from Cycle 1 Day 1 (major surgery is defined as a procedure requiring general anesthesia)
- Active infection requiring systemic therapy. Note: Prophylactic use of antibiotics is allowed. Any infection detected during screening period which is resolved adequately according to investigator before the Cycle 1 Day...
- Known to be human immunodeficiency virus (HIV) positive or have an acquired immunodeficiency syndrome-related illness
- Known active or chronic hepatitis B (HbsAg +ve) or hepatitis C infection (HCV antibody +ve)
- The patient who is expected to require any other form of antineoplastic therapy or targeted therapy while on study.
- Uncontrolled congestive heart failure (New York Heart Association (NYHA) Class 2-4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, or transient ischemic...
- Ongoing cardiac dysrhythmias requiring treatment of any grade or treatment of cardiac dysrhythmias in past 3 months, before Cycle 1 Day 1.
- QTc (Bazzett) interval \>460 ms on ECG at screening and/or at Cycle 1 Day 1 pre-dose.
- Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or significant...
- Current swab-positive or suspected (under investigation) Covid-19 infection or fever and other signs or symptoms suggestive of Covid-19 infection with recent contact of person(s) with confirmed Covid-19 infection, at...
- History of another primary malignancy within 5 years prior to starting study drug, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study.
- Positive pregnancy test for women of child-bearing potential (WOCBP) at the screening or enrolment visit
- Lactating women or WOCBP who are neither surgically sterilized nor willing to use reliable contraceptive methods (hormonal contraceptive, IUD, or any double combination of male or female condom, spermicidal gel...
The study team makes the final eligibility decision.
Where it's taking place
- Visakhapatnam, Andhra Pradesh, India
- Chandigarh, Chandigarh, India
- Ahmedabad, Gujarat, India
- Surat, Gujarat, India
- Rohtak, Haryana, India
- Srinagar, Jammu and Kashmir, India
- Belagavi, Karnataka, India
- Kochi, Kerala, India
- Amravati, Maharashtra, India
- Kolhāpur, Maharashtra, India
- Mumbai, Maharashtra, India
- Nagpur, Maharashtra, India
- Nashik, Maharashtra, India
- Pune, Maharashtra, India
- Thane, Maharashtra, India
- Delhi, National Capital Territory of Delhi, India
- Delhi, New Delhi, India
- Bhubaneswar, Odisha, India
- Hyderabad, Telangana, India
- Kolkata, West Bengal, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Visakhapatnam, Andhra Pradesh, India; Chandigarh, Chandigarh, India; Ahmedabad, Gujarat, India; Surat, Gujarat, India; Rohtak, Haryana, India; Srinagar, Jammu and Kashmir, India and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.