Trials Recruiting at ACTC
|Tumour Stream||Trial Name||Study Description||Key Investigational Agent||Key Inclusion Criteria||Recruitment Status|
|Advanced Solid Organ Tumours||GILEAD (GS-US-494-5484)||A Phase 1b/2 Dose Escalation/Expansion Study to Evaluate the|
Safety, Tolerability, Pharmacokinetics, and Efficacy of GS-4224 in
Subjects with Advanced Solid Tumors
|GS-4224 (small molecule oral PDL1 Inhibitor)|
Daily doing, 3 week cycles
|Advanced Solid Organ Malignancy with no further treatment options. |
TPS/CPS >10% on pre-screening of archival tissue for biopsy sub-study
|Biopsy sub-study Recruiting
Dose Escalation: Recruitment intermittent
|NSCLC, Oesophageal SCC||NP40435||Phase 1b study to evaluate safety, pharmacokinetic and preliminary anti-tumour activity of R07121661, PD-l/TIM3 Bispecific Antibody in patients with advanced and/or metastatic solid tumours||PD1/TIM3 bi-specific antibody|
2 weekly infusions
|-NSCLC: CPI experienced, post platinum, must have received at least 4 months of CPI, PDL1>1% |
- Oesophageal: squamous or adeno-squamous, not more than 1 line of treatment for metastatic disease or recurrence within 24 weeks after chemo-RT/ surgical resection.
|Cervical||AK104-201-AU||A Phase 2, global, multicenter, open-label, single-arm study designed to evaluate the efficacy, safety, tolerability, pharmacokinetic (PK), and immunogenicity of AK104 monotherapy in adult subjects with previously treated recurrent or metastatic cervical carcinoma.||AK104 |
(bispecific antibody targeting CTLA4/ PD-1)
|•Previously treated recurrent or metastatic squamous carcinoma or adeno-squamous carcinoma of the cervix:|
o Disease progression during or following platinum doublet
o No more than 2 prior systemic therapies in recurrent/ metastatic setting
o Not eligible for surgery or radiation as treatment for recurrent disease
o Available archival tissue for PD-L1 assessment.
|Part 1: Melanoma, Urothelial carcinoma|
Prt 2: NSCLC, RCC
|CA20976U||A Phase 1/2 Pharmacokinetic Multi-tumor Study of Subcutaneous Formulation of Ipilimumab|
Monotherapy and in Combination with Subcutaneous Nivolumab
|S/C Ipilimumab monotherapy followed by combination with S/C Nivolumab |
(with recombinant human hyaluronidase)
2-3 weekly infusions
o Melanoma: IO naïve stage IV, prior BRAF/ MEK targeted therapy permitted.
o Urothelial Carcinoma: metastatic or surgically unresectable disease, progression or refractory disease after at least 1 platinum-based chemo regimen (recurrence within 1 year of completing treatment)
o Metastatic NSCLC: Opening soon. Treatment naïve stage IV . Prior adjuvant chemo +/- RT allowed as long as > 6 months from time of completion.
o RCC: No prior treatment lines for stage IV or recurrent disease, IMDC intermediate and poor risk only.
|Part 1: recruiting but closing soon.
Part 2: opening soon
|Advanced solid tumours with established IO indication||BGB-A317-A445-101||Phase 1 Study Investigating the Safety, Tolerability,|
Pharmacokinetics, and Preliminary Antitumor Activity of the
Anti-OX40 Agonist Monoclonal Antibody BGB-A445 in
Combination With the Anti-PD-1 Monoclonal Antibody Tislelizumab
in Patients With Advanced Solid Tumors
|BGB-A445 (OX40 agonist) and Tislelizumab (PD-1 inhibitor) |
Three weekly infusions
|• Phase 1a: Dose Escalation: Includes BGB-A445 monotherapy cohorts and combination cohorts with tislelizumab. Recruitment opens intermittently. |
• Dose Expansion: Closed until phase 1a completed. Details to follow.
|Phase 1a recruiting|
How to Refer
Auckland Cancer Trials Centre
Auckland City Hospital,
2, Park Road, Grafton,
1023, Auckland, New Zealand
Please email all referrals to: CentralReferrals@adhb.govt.nz (include Att: ACTC in email subject)